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Cosmetic Hand Right Female/Youth Adult Extended Wires

by Hugh Steeper Limited

Ref FHEXL8

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number50553482802136 UDI-DI Date3 Jul 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50553482PAH0008J Basic UDI-DI 50553482802136UDI-DIDate12 May 2022RegisteredStatusActive

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.

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  • Withdrawn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
Cosmetic Hand Right Female/Youth Adult Extended Wires EUDAMED
Cosmetic Hand GUDID
Generic Name
Passive hand prosthesis
Device Name
Passive hand prosthesis
Model / Ref / Catalog
FHEXL8, Cosmetic Hand Right Female/Youth Adult Extended Wires
Primary DI / UDI-DI
50553482802136 EUDAMED
05055348280213 GUDID
Basic UDI-DI
50553482PAH0008J
FDA Product Code
IRA
EMDN Code
Y061899 Upper extremity prostheses - other
GMDN Term
Passive hand prosthesis
Device Class
Class I
Regulation Number
890.3420
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FHEXL8
GUDID
Cosmetic Hand Right Female/Youth Adult Extended Wires
Primary DI / UDI-DIEUDAMED
50553482802136
GUDID
05055348280213

Manufacturer details

EUDAMED SRN
GB-MF-000010196
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Hugh Steeper Limited

See all devices from Hugh Steeper Limited →

Properties

  • Premarket Exempt

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No