Skip to content

Newclip Instruments ANC1428

by Newclip Technics

Part of a family of 65 devices: see the family page

Ref ANC1428

Newclip Instruments ANC1428 is a Class I device made by Newclip Technics, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 3700569600569B) and listed in FDA GUDID since 7 Nov 2024 (UDI-DI 03700569663971), 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 Number3700569600569B Basic UDI-DI 03700569663971UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569663971 UDI-DI Date7 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3700569600569B registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 03700569663971 listed 7 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700569663971
  2. Registered EUDAMED 3700569600569B

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  • Withdrawn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
Surgical drill guide, reusable
Device name
Instruments for trauma and orthopaedic surgery
Model / Ref / Catalog
ANC1428
Primary DI / UDI-DI
03700569663971
Basic UDI-DI
3700569600569B
FDA product code
FZX
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical drill guide, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Newclip Technics

  • Alians Forearm HTSIS2-ST

    Class II

  • QBT2.8L18-St

    Class II

  • QBT2.8L20-St

    Class II

  • QBT2.8L22-St

    Class II

See all devices from Newclip Technics →

Properties

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