CE Mark
TÃœV Rheinland
Quality management
Certified by the registrars buyers verify.
Every certificate links to its registrar database. No badge wall theatre — the documentation that EU MDR and FDA buyers actually ask for.
Current certifications
EU MDR / EUDAMED
EUDAMED
FDA 510(k)
U.S. FDA
GS1 UDI
GS1
ISO 13485:2016
TÃœV SÃœD
ISO 9001:2015
BSI
Audit-ready, not audit-promised.
Procurement officers buying instruments from new suppliers want one thing in the certification slot: the actual paperwork. Not a badge. Not a phrase. The PDF with the registrar name, certificate number, issue date, expiry date, and a verification link to the registrar’s database. That is how a Notified Body or FDA reviewer treats certification, and it is how we present ours.
Standards we hold
Every cert below links to its current scan and to the registrar’s verification portal. If a scan or verification link is not yet shown, email qc@ajbrothersent.com and we will send the PDF directly within one business day.
- ISO 13485:2016 — Medical devices quality management system. The framework all our document control, design control, lot traceability, and CAPA processes run on.
- CE Mark — for in-scope dental and surgical instruments per the EU Medical Devices Regulation (MDR 2017/745). Class I non-sterile, non-measuring per Annex VIII Rule 1.
- EU MDR / EUDAMED — UDI registration for affected SKUs. Basic-UDI-DI assigned per product family; UDI-DI per packaging level.
- FDA 510(k) — where applicable. Most of our catalog falls under FDA general dental instruments (21 CFR 872) and general & plastic surgery instruments (21 CFR 878) — Class I, general controls, 510(k)-exempt for the relevant codes.
- GS1 UDI — barcode plus human-readable on outer carton; lot card matches.
- ISO 9001:2015 — general quality management system, broader than 13485, kept current for non-medical OEM customers.
What an audit looks like
We host distributor and procurement audits with two weeks’ notice. A typical visit takes one working day:
- QC walk-through of incoming raw-material certification plus lot books
- Live observation of forging, polishing, marking, and packing stations
- Document-control sample: pick any lot ever shipped, we pull the QC certificate, the dimensional check sheet, the polish sign-off, and the carton lot card on the spot
- Closing meeting and photographs (allowed; we welcome the documentation)
See the manufacturing station-by-station detail or book a factory audit.
Frequently asked questions
Are your instruments single-use or reusable?
Reusable, autoclavable per the spec sheet sterilisation matrix. Single-use kits are available as OEM with explicit single-use packaging and marking.
Do you have FDA 510(k) clearance on every instrument?
No — most of our general dental and surgical instruments are 510(k)-exempt under their respective FDA product codes. Where 510(k) is required for a specialty SKU, we either hold it or build it onto the buyer’s 510(k). Confirm per product line with QC.
Can you ship to my Notified Body for inspection?
Yes — coordinated with your OEM or QA team. We have shipped sample sets to TÜV SÜD, BSI, and Intertek inspection laboratories on prior audits.
What is your CAPA turnaround if we open a complaint?
Investigation initiated within 5 working days of receipt of a documented complaint; preliminary findings within 15; corrective action plan within 30. Tracked under our ISO 13485 CAPA register, available on request to active customers.
Ready to request a quote?
Our team replies within one business day. Mon–Sat, Sialkot office hours.