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Xpert Wrist DMTSD1-ST

by Newclip Technics

Ref DMTSD1-ST

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213214

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3700569600138R Basic UDI-DI 03700569648800UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700569648800 UDI-DI Date14 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213214 Date24 Nov 2021DecidedStatusActive

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Xpert Wrist
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Plates Xpert Wrist
Model / Ref / Catalog
DMTSD1-ST
Primary DI / UDI-DI
03700569648800
Basic UDI-DI
3700569600138R
510(k) Number
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K213214)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Lot / batch number
  • Expiration date

Other properties (20)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No