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Another Hand

by Wismed (Pty) Ltd

Ref URO 049

Another Hand (URO 049) is a surgical instrument handle grip (EU MDR Class I; FDA Class I; FDA product code EYJ, Holder, Ureteral Catheter) made by Wismed (PTY) Ltd, registered in EUDAMED on 22 Jul 2024 (Basic UDI-DI 60099004083URO0493N) and listed in FDA GUDID since 17 Mar 2025 (UDI-DI 06009900639604), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06009900639604 UDI-DI Date17 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number60099004083URO0493N Basic UDI-DI 06009900639604UDI-DIDate22 Jul 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 60099004083URO0493N registered 22 Jul 2024 Active
  • FDA GUDID UDI-DI 06009900639604 listed 17 Mar 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 60099004083URO0493N
  2. Listed FDA GUDID 06009900639604

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  • Withdrawn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

Generic name
Surgical instrument handle grip
Model / reference
URO 049 EUDAMED
1 GUDID
Primary DI / UDI-DI
06009900639604
Basic UDI-DI
60099004083URO0493N
FDA product code
EYJ
EMDN code
V0880 Medical support equipment - accessories
GMDN term
Surgical instrument handle grip
Device class
Class I
Regulation number
876.5130
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
URO 049
GUDID
1

Manufacturer details

EUDAMED SRN
ZA-MF-000035555
Authorised representative
TNMC Devices Llc HR-AR-000019582

Similar devices in this category

Other devices filed under MEDICAL SUPPORT EQUIPMENT - ACCESSORIES.

Other devices from Wismed (PTY) Ltd

See all devices from Wismed (PTY) Ltd →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)