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Instruments IIa

by Newclip Technics SAS 46 variants

Part of a family of 67 devices: see the family page

Ref ANC1783-ST

Instruments IIa (ANC1783-ST) 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 27 Apr 2026 (Basic UDI-DI 3700569600479A) and listed in FDA GUDID since 7 May 2026 (UDI-DI 03700569677558), 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
United StatesGUDID listing GUDID Number03700569677558 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3700569600479A Basic UDI-DI 03700569677558UDI-DIDate27 Apr 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3700569600479A registered 27 Apr 2026 Active
  • FDA GUDID UDI-DI 03700569677558 listed 7 May 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 3700569600479A
  2. Listed FDA GUDID 03700569677558

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  • Withdrawn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 implant template, single-use
Device name
Instruments IIa
Model / Ref / Catalog
ANC1783-ST
Primary DI / UDI-DI
03700569677558
Basic UDI-DI
3700569600479A
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Surgical implant template, single-use
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

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

Related devices

Category: Joint prosthesis implantation kit, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Newclip Technics SAS

See all devices from Newclip Technics SAS →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)