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Newclip Instruments KIT-SC2.6F

by Newclip Technics

Part of a family of 26 devices: see the family page

Ref KIT-SC2.6F

Newclip Instruments KIT-SC2.6F is a device classified as Class IIa in the EU and Class I in the US made by Newclip Technics, registered in EUDAMED on 12 May 2026 (Basic UDI-DI 3700569600669E) and listed in FDA GUDID since 14 Nov 2024 (UDI-DI 03700569633882), 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 Number3700569600669E Basic UDI-DI 03700569633882UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569633882 UDI-DI Date14 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3700569600669E registered 12 May 2026 Active
  • FDA GUDID UDI-DI 03700569633882 listed 14 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700569633882
  2. Registered EUDAMED 3700569600669E

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  • Withdrawn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
General internal orthopaedic fixation system implantation kit
Device name
Instrumentation class IIa with measuring function
Model / Ref / Catalog
KIT-SC2.6F
Primary DI / UDI-DI
03700569633882
Basic UDI-DI
3700569600669E
FDA product code
FSM
EMDN code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
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.

Related devices

Category: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE.

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Properties

  • Supplied sterile
  • Single use
  • Measuring function
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)