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Instrumentation class IIa

by Newclip Technics SAS 20 variants

Part of a family of 24 devices: see the family page

Ref ANC289

Instrumentation class IIa (ANC289) is a device classified as Class IIa in the EU and Class I in the US made by Newclip Technics SAS, registered in EUDAMED on 12 May 2026 (Basic UDI-DI 37005696004698) and listed in FDA GUDID since 11 May 2026 (UDI-DI 03700569621063), 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 Number37005696004698 Basic UDI-DI 03700569621063UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569621063 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 37005696004698 registered 12 May 2026 Active
  • FDA GUDID UDI-DI 03700569621063 listed 11 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700569621063
  2. Registered EUDAMED 37005696004698

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  • Withdrawn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
Newclip Instruments
Generic name
Fluted surgical drill bit, reusable
Device name
Instrumentation class IIa
Model / Ref / Catalog
ANC289
Primary DI / UDI-DI
03700569621063
Basic UDI-DI
37005696004698
FDA product code
HTW
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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.

Manufacturer details

EUDAMED SRN
FR-MF-000011809

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Newclip Technics SAS

See all devices from Newclip Technics SAS →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)