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Plates Xpert Hand

by Newclip Technics SAS 14 variants

Ref PTSH1D

Plates Xpert Hand (PTSH1D) is a device classified as Class IIb in the EU and Class II in the US made by Newclip Technics SAS, registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 3700569600689J) and listed in FDA GUDID since 13 Apr 2026 (UDI-DI 03700569681807), 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 Number3700569600689J Basic UDI-DI 03700569681807UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569681807 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3700569600689J registered 15 Jul 2026 Active
  • FDA GUDID UDI-DI 03700569681807 listed 13 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700569681807
  2. Registered EUDAMED 3700569600689J

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  • Withdrawn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
Xpert Hand
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Plates Xpert Hand
Model / Ref / Catalog
PTSH1D
Primary DI / UDI-DI
03700569681807
Basic UDI-DI
3700569600689J
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II 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 BONE FIXATION PLATES - OTHER.

Other devices from Newclip Technics SAS

See all devices from Newclip Technics SAS →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)