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Newclip Instruments ANC591

by Newclip Technics

Part of a family of 84 devices: see the family page

Ref ANC591

Newclip Instruments ANC591 is a device classified as Class IIa in the EU and Class I in the US made by Newclip Technics, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 3700569600679G) and listed in FDA GUDID since 8 Nov 2024 (UDI-DI 03700569622503), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3700569600679G Basic UDI-DI 03700569622503UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569622503 UDI-DI Date8 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3700569600679G registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 03700569622503 listed 8 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700569622503
  2. Registered EUDAMED 3700569600679G

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  • Withdrawn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
Instruments for trauma and orthopaedic surgery
Model / Ref / Catalog
ANC591
Primary DI / UDI-DI
03700569622503
Basic UDI-DI
3700569600679G
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.

Related devices

Category: Fluted surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

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Properties

  • Sterilise before use
  • Reusable
  • Measuring function
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)