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Smart Bulb

by Wismed (Pty) Ltd

Ref URO 037

Smart Bulb (URO 037) is a surgical irrigation tubing set (EU MDR Class I; FDA Class I; FDA product code FFY, Adaptor, Bulbs, Miscellaneous, For Endoscope) made by Wismed (PTY) Ltd, registered in EUDAMED on 24 Jul 2024 (Basic UDI-DI 60099004083URO0373F) and listed in FDA GUDID since 17 Mar 2025 (UDI-DI 06009900408330), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06009900408330 UDI-DI Date17 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number60099004083URO0373F Basic UDI-DI 06009900408330UDI-DIDate24 Jul 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 60099004083URO0373F registered 24 Jul 2024 Active
  • FDA GUDID UDI-DI 06009900408330 listed 17 Mar 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 60099004083URO0373F
  2. Listed FDA GUDID 06009900408330

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  • Withdrawn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 irrigation tubing set, single-use
Model / reference
URO 037 EUDAMED
1 GUDID
Primary DI / UDI-DI
06009900408330
Basic UDI-DI
60099004083URO0373F
FDA product code
FFY
EMDN code
Z12019007 Irrigators
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class I
Regulation number
876.1500
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 037
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 IRRIGATORS.

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)