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Regulatory Compliance Portal

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US FDA approved & registered (Green List, Import Alert 76-01) — and accredited and certified to ISO 13485, ISO 9001, ISO 14001, ISO 45001 & ISO 7153-1. Acheron Instruments is an FDA-registered, CE-marked certified surgical & dental instruments manufacturer. Download the US FDA letter, EU MDR / Notified Body certificates, ISO certificates, IFU, GSPR, test reports and UDI labels instantly — no emails, no waiting.

Compliance Overview
FDA
Green List 76-01
CE
EU MDR / NB 1282 · In Process
13485
ISO QMS
7
ISO Standards
10,000+
Product SKUs
FSC
Export Approved (MOH)
US FDAGREEN LIST 76-01 · FEI 3011600579 · O/O 10093859
EU MDRNB 1282 · IN PROCESS
CE MarkPAK-MD-CE-440
ISO 13485CERT 920270
SRNPK-MF-000037497
Home› Compliance Hub
Priority — United States Market Access
US FDA Compliance
FEI 3011600579 · Green List 76-01
U.S. Food & Drug Administration · CDRH

Green List of Import Alert 76-01

Acheron Instruments (Pvt.) Ltd is placed on the Green List of Import Alert 76-01 — "Exempt from Detention Without Physical Examination of Medical Instruments from Pakistan." Compliance with the FDA Quality System Regulation (21 CFR Part 820 / cGMP) was acknowledged by CDRH in the official FDA letter.

FEI Number3011600579
Owner/Operator No.10093859
Regulation21 CFR Part 820 (cGMP)
Import Alert76-01 — Green List
ScopeNon-active surgical, dental, eye/ophthalmic
Material StdASTM F899-12b stainless
CDRH Letter21 Oct 2021
FDA Establishment Registration → Verify Import Alert 76-01 →
US FDA cGMP Acknowledgement Letter (CDRH)
✓ FDA / CDRHPDF · 3 pages21 Oct 2021
Official FDA letter confirming cGMP / 21 CFR 820 compliance and placement on the Green List of Import Alert 76-01. FEI 3011600579.
✓ FDA

US importers / distributors: Establishment registration & device listing are renewed annually with FDA. Reference our FEI 3011600579 in correspondence. Request our current registration confirmation and listing extract from the compliance team. Email compliance team →

European Union
EU MDR, Notified Body & CE
SRN PK-MF-000037497
Declaration of Conformity 2026 — EU MDR 2017/745
✓ Annex IVPDF2026
Manufacturer's DoC for Class I / Ir reusable surgical & dental instruments per MDR 2017/745, Annex IV.
✓ MDR
NB 1282 Confirmation Letter — Reg. (EU) 2023/607
✓ ECM · NB 1282MDR Certification In ProcessPDF · 4 pages24 May 2024
Ente Certificazione Macchine (NB 1282) confirms formal MDR application & written agreement under Reg. (EU) 2023/607. Ref 91/F. Transition to 31 Dec 2028 for re-usable surgical instruments.
✓ NB 1282
EU Authorised Representative (EAR) Certificate
✓ KB InternationalPDF · 2 pages27 Mar 2026 – 26 Mar 2027
KB International (SRN HU-AR-000034102), Budapest — Reg. EAR/PK/7307. Surgical & Dental Instruments, Class I & Ir, Annex VIII. Includes 39-product Annex A list.
✓ EAR
CE Certificate — Class I (PAK-MD-CE-440)
✓ CAIPDF29 Sep 2025 – 28 Sep 2026
CE marking for Surgical, Dental & Eye/Ophthalmic Instruments (Class I). Certificate No. PAK-MD-CE-440.
✓ CE

Manufacturer SRN: PK-MF-000037497 · EU Authorised Rep: KB International, Auróra utca 13. al. 1, 1084 Budapest, Hungary (SRN HU-AR-000034102). Devices are Class I / Ir under MDR 2017/745, Annex VIII.

Government & Trade Credentials
Free Sales Certificate & Memberships
Ministry of Health · Chambers
Free Sales Certificate (FSC) — Export Approval
✓ Govt. of Punjab · DHOJPGRef 663-DHO(MS)
Free Sales Certificate for exportation of medical devices, issued by the Office of the District Health Officer (Medical Services), Government of Punjab. Confirms products may be freely distributed in Pakistan and exported worldwide per Ministry of Health guidance — surgical, dental, orthopedic, eye/ophthalmic, laparoscopic & veterinary instruments.
✓ MOH
SIMAP Membership — Surgical Instruments Mfrs. Assoc. of Pakistan
✓ SIMAPJPGSialkot
Active membership of the Surgical Instruments Manufacturers Association of Pakistan (affiliated with the Federation of Pakistan Chambers of Commerce & Industry). Serial No. 999031.
✓ SIMAP
LCCI Membership — Lahore Chamber of Commerce & Industry
✓ LCCIJPGMember since 08 May 2015
Membership certificate of the Lahore Chamber of Commerce & Industry (affiliated with the Federation of Pakistan Chambers of Commerce & Industry). Membership No. 84765-A.
✓ LCCI
Management Systems & Material
ISO Standards & REACH
8 certificates
Medical Devices QMS
ISO 13485:2016
CERT 920270 (LL-C)
Valid to 28 Sep 2028Active
Quality MS
ISO 9001:2015
PAK-Q-900440
Valid to 28 Sep 2026Active
Environmental MS
ISO 14001:2015
PAK-E-140440
Valid to 28 Sep 2026Active
Occupational H&S
ISO 45001:2018
PAK-H-450440
Valid to 23 Nov 2026Active
Surgical Materials
ISO 7153-1:2016
PAK-S-710440
Valid to 28 Sep 2026Active
Autoclave / Corrosion
ISO 13402:2025
RCLQ1001967
Valid to 20 Feb 2027Active
Device Processing
ISO 17664-1:2021
RCLQ1001968
Valid to 20 Feb 2027Active
EU Substances
REACH
RCLQ1001969
Valid to 20 Feb 2027Active
ISO 13485:2016 — Medical Devices QMS
✓ LL-CPDF31 Oct 2025 – 28 Sep 2028
Quality Management System for Medical Devices. Certificate No. 920270 (v2), IAF/MLA accredited.
✓ LL-C
ISO 9001:2015 — Quality Management System
✓ CAIPDFto 28 Sep 2026
Certificate No. PAK-Q-900440. Manufacturing & export of surgical, dental and allied instruments.
✓ ISO
ISO 14001:2015 — Environmental Management
✓ CAIPDFto 28 Sep 2026
Certificate No. PAK-E-140440. Environmental management system for instrument manufacturing.
✓ ISO
ISO 45001:2018 — Occupational Health & Safety
✓ CAIPDFto 23 Nov 2026
Certificate No. PAK-H-450440. OH&S management system.
✓ ISO
ISO 7153-1:2016 — Surgical Instrument Materials
✓ CAIPDFto 28 Sep 2026
Certificate No. PAK-S-710440. Metals for surgical instruments — technical documentation & test reports.
✓ ISO
ISO 13402:2025 — Autoclaving, Corrosion & Thermal
✓ Reliable Cert.PDFto 20 Feb 2027
Certificate No. RCLQ1001967. Resistance against autoclaving, corrosion and thermal exposure.
✓ ISO
ISO 17664-1:2021 — Processing of Health Care Products
✓ Reliable Cert.PDFto 20 Feb 2027
Certificate No. RCLQ1001968. Reprocessing information for critical & semi-critical devices.
✓ ISO
REACH Certificate & EU REACH Declaration
✓ Reliable Cert.PDFto 20 Feb 2027
Certificate No. RCLQ1001969 plus EU REACH declaration — no SVHC / restricted substances above 0.1% w/w.
✓ REACH
Instructions for Use & Safety
IFU & GSPR Documents
Reusable surgical & dental instruments
Instructions for Use (IFU) — Reusable Surgical & Dental Instruments
✓ ISO 17664PDF · 4 pagesFor professional use only
Full reprocessing instructions: point-of-use prep, manual & ultrasonic cleaning, disinfection, drying, lubrication, packaging, vacuum-autoclave sterilization (134 °C, do not exceed 150 °C), storage and disposal. Supplied non-sterile.
GSPR Checklist — MDR 2017/745 Annex I
✓ MDR Annex IPDF · 46 pagesRev 0 · 01 Jul 2024
General Safety & Performance Requirements checklist for reusable surgical instruments. Classification: Class I, Annex VIII, Rules 1, 5, 6. Doc. ACHERON-GSPR-RSI01.
Material Verification
Material Safety & Test Reports
PCSIR · ISO 10993-1
Chemical Analysis Test Report — PCSIR (Govt. of Pakistan)
✓ PCSIR CM&FTPDF01 Sep 2020
Independent chemical composition analysis (Micro Castroviejo Needle Holder) — confirmed compatible with AISI 420. Ref CMFT/ILO/20/20877. C 0.20, Cr 13.0, Fe balance.
✓ PCSIR
Material Safety Data Sheet (MSDS) — ISO 10993-1
✓ ISO 10993-1PDF · 6 pagesRev 0 · 01 May 2021
Material safety analysis for surgical-grade stainless steel (BS EN ISO 7153-1, 13402; BS 5194 series). Risk & hazard assessment — no known risk or hazard to patients or users. Doc AI-MSDS-01.
✓ ISO 10993
Device Identification
UDI Labels — Reference Catalogue
Class Ir · Non-sterile · LOT 284-TR
Product NameREF (Catalogue No.)CategoryClassLabel
Backhaus Towel Forceps 4¼" (11 cm)AI-GS-02-035General SurgeryClass Ir
Backhaus Towel Forceps 3½" (9 cm)AI-GS-02-033General SurgeryClass Ir
Adson Dressing Forceps — Standard, 1.3mm (12 cm)AI-GS-02-071General SurgeryClass Ir
Adson Dressing Forceps — Delicate, 1.2mm (12.5 cm)AI-GS-02-072General SurgeryClass Ir
Adson Dressing Forceps TC — Standard (12 cm)AI-GS-02-073General SurgeryClass Ir
Dressing Forceps — Curved, Fine Point Serrated (12.5 cm)AI-GS-02-093General SurgeryClass Ir
Jansen Bayonet Dressing Forceps — Serrated, 2.1mm (16 cm)AI-GS-02-095General SurgeryClass Ir
Semken Dressing Forceps — Serrated (12.5 cm)AI-GS-02-111General SurgeryClass Ir

Labels carry CE mark, MD symbol, non-sterile & 134 °C autoclavable symbols, QR/DataMatrix UDI carrier, LOT, and manufacture date. EU Authorised Rep: KB International, Budapest. Download the full UDI label sheet for all product variants. Download UDI label sheet →

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