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Offset coupling, Z/H 9209-1306

by Enztec Limited

Part of a family of 113 devices: see the family page

Ref 9209-1306

Offset coupling, Z/H 9209-1306 is a device classified as Class IIa in the EU and Class I in the US made by Enztec Limited, registered in EUDAMED on 27 Mar 2026 (Basic UDI-DI 942102811GMN003022) and listed in FDA GUDID since 9 Mar 2026 (UDI-DI 09421038412152), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number942102811GMN003022 Basic UDI-DI 09421038412152UDI-DIDate27 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09421038412152 UDI-DI Date9 Mar 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 942102811GMN003022 registered 27 Mar 2026 Active
  • FDA GUDID UDI-DI 09421038412152 listed 9 Mar 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 09421038412152
  2. Registered EUDAMED 942102811GMN003022

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Offset coupling, Z/H
Generic name
Surgical power tool adaptor
Device name
Reamer Drivers and Acetabular Reamers
Model / Ref / Catalog
9209-1306
Primary DI / UDI-DI
09421038412152
Basic UDI-DI
942102811GMN003022
Direct marketing DI
09421038412152
FDA product code
HWE
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical power tool adaptor
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Enztec Limited

See all devices from Enztec Limited →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)