Certifications & Compliance

Certifications & Compliance

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EndoTech Certifications & Compliance

Certifications & Compliance for Surgical & Dental Instruments

Review EndoTech's documented quality and regulatory certificates, including the CE Compliance Certificate under MDR 2017/745 and the ISO 13485:2016 certificate for manufacturers and exporters of surgical and dental instruments.

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ISO 13485:2016 CE / MDR 2017/745 Surgical Instruments Dental Instruments USA Buyer Support
Documented Certificate Scope

Medical Device Quality & Regulatory Documentation

The certificates supplied for this page identify ENDO TECH INSTRUMENTS as the manufacturer and cover reusable surgical and dental instruments within the stated certificate scopes.

Document-status notice:
The certificate documents shown on this page were issued in December 2023 and show expiry dates in December 2024. They are presented as documented historical certificates. For current procurement, regulatory or U.S. market verification, request EndoTech's current certificate and applicable regulatory documents.
Certification Overview

What the Documented Certificates Cover

The supplied documents provide two distinct certification records: a CE compliance certificate referencing Medical Device Regulation (MDR) 2017/745 and an ISO 13485:2016 quality management certificate. The third supplied ISO image is a duplicate of the second.

Certificate 01

CE Compliance Certificate — Medical Devices Class I

The supplied CE certificate identifies reusable surgical and dental instruments as the product category and references MDR 2017/745, Medical Devices Class I and registration number DCS/122910622-A.

Certificate 02

ISO 13485:2016 Certificate

The supplied ISO certificate identifies ENDO TECH INSTRUMENTS and states the approved scope as manufacturers and exporters of surgical & dental instruments, under registration number DCS/1460-B.

Important Certificate Validity Information

The certificate images supplied for publication show historical certificate periods. The CE certificate shows an expiry date of 11 December 2024, while the ISO 13485:2016 certificate shows an expiry date of 27 December 2024. Because those dates have passed, this page does not represent either document as a currently valid certificate. USA importers, distributors and other regulated buyers should request the current certificate set and applicable product documentation directly from EndoTech before procurement or regulatory reliance.

Certificate Documents

EndoTech Certification Records

The following images are the certificate documents supplied for this page. Certificate information below follows the supplied documents.

EndoTech CE Compliance Certificate Medical Devices Class I MDR 2017/745
Certificate 01

CE Compliance Certificate

Certification Body Dynamex Certification Services (DCS)
Regulation Medical Device Regulation MDR 2017/745
Classification Medical Devices Class I
Product Category Re-Usable Surgical and Dental Instruments
Registration No. DCS/122910622-A
Manufacturer ENDO TECH INSTRUMENTS
Issue Date 12 December 2023
Expiry Date 11 December 2024
Certificate statement: The supplied certificate states that the applicable products comply with MDR 2017/745 and that the technical file was assessed, including the EC Declaration of Conformity according to Annex IV.
Certificate limitation: The certificate states that substantial changes to the product or process must be communicated to Dynamex Certification Services to determine whether the certificate remains valid.
EndoTech ISO 13485:2016 certificate manufacturers and exporters of surgical and dental instruments
Certificate 02

ISO 13485:2016 Certificate

Certification Body Dynamex Certification Services (DCS)
Standard ISO 13485:2016
Registration No. DCS/1460-B
Certified Organization ENDO TECH INSTRUMENTS
Issue Date 13 December 2023
Expiry Date 27 December 2024
Initial Registration 28 December 2018
Re-assessment Date 27 December 2024
Approved scope:
“MANUFACTURERS AND EXPORTERS OF SURGICAL & DENTAL INSTRUMENTS”
Certification body: Dynamex Certification Services. The supplied certificate states that the certificate is granted subject to the regulations approved by the Board.
Scope & Compliance Meaning

Understanding EndoTech's Documented Compliance

Certification documents are useful to procurement teams because they define the organization, standard or regulation, scope, certification body and certificate period. Buyers should review the exact document and applicable scope rather than relying on a generic certification statement.

ISO 13485:2016

The supplied certificate is a quality management-system certificate for ENDO TECH INSTRUMENTS. Its stated scope is manufacturing and exporting surgical and dental instruments.

Scope shown on the certificate: “MANUFACTURERS AND EXPORTERS OF SURGICAL & DENTAL INSTRUMENTS”

CE Compliance — MDR 2017/745

The supplied CE document identifies Medical Devices Class I and reusable surgical and dental instruments. It references MDR 2017/745 and states that the technical file was assessed.

Registration: DCS/122910622-A

Certification Body

Both supplied certificate records identify Dynamex Certification Services (DCS) as the certification body.

The certification organization website shown on the supplied certificates is: www.dynamexcertification.org

Manufacturer Identification

The certificates identify the manufacturer or certified organization as ENDO TECH INSTRUMENTS.

Address shown on the supplied documents: Al-Muslim Street #5, Islam Nagar Road Pacca Garah, Sialkot – 51310, Pakistan.

Compliance Documentation

What Procurement Teams Should Verify

A certification document should always be reviewed together with the product, intended market, certificate scope and certificate period. This is particularly important for regulated medical device procurement.

01

Certificate Identity

Check the manufacturer name, certificate number, certification body and the standard or regulation named on the document.

02

Scope

Verify that the certificate scope corresponds to the products and activities being purchased or evaluated.

03

Validity Period

Check issue and expiry dates before relying on a certificate. An historical certificate should not automatically be treated as current.

04

Product Documentation

Request any product-specific declarations, technical documents, labeling information or regulatory records required for the destination market.

05

Market Requirements

Regulatory requirements differ by market and product. U.S. importers should verify the documentation required for the particular device and intended use.

06

Current Documents

For active procurement, ask EndoTech for the current certificate set rather than relying solely on older certificates displayed for historical documentation.

Ongoing Compliance

Compliance Is More Than Displaying a Certificate

EndoTech's current company information states that quality is monitored through production and that its Quality Assurance Management team monitors the manufacturing process from raw material selection through final inspection. :chatgpt-content-reference{index="1"}

Quality-Control Activities

  • Raw material selection and review
  • In-process manufacturing checks
  • Measurement and dimensional checking
  • Surface and workmanship review
  • Final inspection before shipment

Document Control for Buyers

For regulated procurement, EndoTech buyers can request the documentation applicable to their products and market. The correct document set depends on the instrument, intended use, destination market and current regulatory status.

For current certification documents, use EndoTech Contact Us rather than relying on expired historical certificate images.

USA Importer & Distributor Compliance

Certification Documentation for U.S. Surgical Instrument Buyers

EndoTech's current company information says it serves buyers in more than 55 countries and has long-standing relationships with wholesale distributors and medical supply companies in the United States. :chatgpt-content-reference{index="2"}

What a USA Importer Should Request

Certification documents are only one part of medical device procurement. U.S. importers and distributors should evaluate the applicable current documentation for the specific product before placing an order.

  • Current quality-management certificate
  • Current CE or other applicable market documentation
  • Product-specific declarations where applicable
  • Manufacturer identification and certificate scope
  • Current regulatory status for the product and destination market
  • Labeling and documentation requirements for the intended market
  • Export and shipping documentation required for the order

Request the Current Certificate Set

The certificate images on this page document the certificate records supplied by EndoTech. Because the displayed validity periods ended in 2024, USA buyers should request current documentation before relying on these records for procurement, compliance or import decisions.

EndoTech can also discuss product-specific documentation, quantities, packaging and international shipment requirements.

This page describes the supplied certificates and does not substitute for product-specific regulatory review by the buyer, importer or applicable authority.

Document Archive

Additional ISO 13485 Certificate Image

The third certificate image supplied for this page is a duplicate of the ISO 13485:2016 certificate shown above.

Duplicate image of EndoTech ISO 13485:2016 certificate
Duplicate Certificate Image

ISO 13485:2016 — Same Certificate Record

This image contains the same certificate information as the second certificate image: ENDO TECH INSTRUMENTS, registration number DCS/1460-B, ISO 13485:2016, and the scope “MANUFACTURERS AND EXPORTERS OF SURGICAL & DENTAL INSTRUMENTS.”

It is displayed separately for document transparency but should not be interpreted as a third distinct certification.

Certification Verification

Key Certificate Information at a Glance

Use these details when checking the supplied certificate records against procurement documentation.

CE Registration DCS/122910622-A
ISO Registration DCS/1460-B
Certification Body Dynamex Certification Services (DCS)
Manufacturer ENDO TECH INSTRUMENTS
CE Regulation MDR 2017/745
CE Classification Medical Devices Class I
ISO Standard ISO 13485:2016
Certificate Scope Manufacturers and exporters of surgical & dental instruments
Explore EndoTech

Related Products, Manufacturing & Company Information

These links connect certification information with the relevant EndoTech product, manufacturing and sourcing pages.

About EndoTech Company history, quality systems and international experience. Manufacturing Strength Explore EndoTech's production capabilities and manufacturing process. Surgical Instrument Catalogue Review EndoTech's broader product catalogue. ENT Instruments Explore the ENT surgical instrument product category. Retractors Instruments Explore EndoTech's surgical retractor instruments. Orthopedic Instruments Explore orthopedic surgical instrument products. Gynecology Instruments Explore gynecology surgical instrument products. Dental Instruments Explore EndoTech's dental instrument product category. Kerrison Rongeur Explore Kerrison Rongeur instruments. Instrument Care Care and handling information for surgical instruments. OEM ENT Instruments Dedicated OEM sourcing page for ENT instruments. Contact EndoTech Request current certification and compliance documents.
Certifications & Compliance FAQ

Frequently Asked Questions

Clear answers about the certification documents shown on this page and what USA and international buyers should verify.

What certifications are documented on this page?
Two distinct certificates are documented: a CE Compliance Certificate referencing MDR 2017/745 for Medical Devices Class I and an ISO 13485:2016 certificate for ENDO TECH INSTRUMENTS. The third supplied certificate image is a duplicate of the ISO certificate.
What is the CE certificate registration number?
The supplied CE Compliance Certificate shows registration number DCS/122910622-A.
What regulation is referenced on the CE certificate?
The supplied certificate references the European Medical Device Regulation MDR 2017/745 and identifies the devices as Medical Devices Class I.
What products are covered by the supplied CE certificate?
The supplied document identifies the product category as Re-Usable Surgical and Dental Instruments.
What is EndoTech's ISO 13485 certificate number?
The supplied ISO 13485:2016 certificate shows registration number DCS/1460-B.
What is the scope of the ISO 13485 certificate?
The supplied certificate states the scope as: “MANUFACTURERS AND EXPORTERS OF SURGICAL & DENTAL INSTRUMENTS.”
Who issued the certificates?
Both supplied certificate records identify Dynamex Certification Services (DCS) as the certification body.
Are the certificate documents shown on this page currently valid?
The supplied CE certificate shows an expiry date of 11 December 2024, and the supplied ISO 13485 certificate shows an expiry date of 27 December 2024. Therefore, this page does not represent these documents as currently valid certificates. Buyers should request EndoTech's current certificate set.
Is the third certificate image a separate certification?
No. Based on the supplied information, the third image is a duplicate of the ISO 13485:2016 certificate shown as Certificate 02. It is displayed for document transparency only.
Can USA importers request current compliance documents?
Yes. USA importers and distributors should contact EndoTech to request the current certificates and product-specific documentation applicable to their products and intended market.
Does an ISO 13485 certificate apply to every individual instrument?
ISO 13485 is a quality management-system standard. The exact product, regulatory and certification scope should be checked against the applicable documentation rather than assuming that one certificate automatically establishes the same status for every individual product.
Where can buyers request certification documents?
Buyers can contact EndoTech through the Contact Us page to request the current documentation relevant to their procurement requirements.
Request Current Compliance Documentation

Need EndoTech's Current Certificates for Procurement or Compliance Review?

Contact EndoTech with your product list, destination market and procurement requirements to request the current certification and compliance documents applicable to your order.

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