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Disposable Urine Collection Tube

by Zhejiang Gongdong Medical Technology Co., Ltd.,

Ref GD040UA, GD0100UB, GD0120SEC, GD0100UA, GD050UB, GD070UB, GD090UB, GD0105UB, GD080SEC, GD060UB, GD0100UBFBModel No addition, boric acid, Sodium Propionate +Ethyl Paraben+ Chlorhexidine, boric acid + sodium formate + sodium borate

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

CE IVDR 510(k)

Valid until

Not listed

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) K220739↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number6947462411111154LY Basic UDI-DI Date17 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06947462401720 UDI-DI Date13 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK220739 Date17 Nov 2022IssuedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Disposable Urine Collection Tube EUDAMED
Gongdong GUDID
Generic Name
Evacuated urine specimen container IVD, preservative
Model / Reference
No addition, GD040UA, boric acid, GD0100UB, Sodium Propionate +Ethyl Paraben+ Chlorhexidine, GD0120SEC, GD070UB, GD0100UA, GD050UB, GD090UB, GD0105UB, GD080SEC, GD060UB, boric acid + sodium formate + sodium borate, GD0100UBFB
Primary DI / UDI-DI
06947462401720 EUDAMED
06947462433226 EUDAMED
06947462435107 EUDAMED
06947462401737 EUDAMED
06947462433172 EUDAMED
06947462433196 EUDAMED
06947462433219 EUDAMED
06947462433233 EUDAMED
06947462436326 EUDAMED
06947462433189 EUDAMED
06947462401751 EUDAMED
16947462494286 GUDID
Basic UDI-DI
6947462411111154LY, 6947462411111166M7, 6947462411111194MC, 6947462411111157M6
FDA Product Code
JSM
EMDN Code
W05010202 Urine collection, tubes
GMDN Term
Evacuated urine specimen container IVD, preservative
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
866.2390
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06947462401720
06947462433226
06947462435107
06947462401737
06947462433172
06947462433196
06947462433219
06947462433233
06947462436326
06947462433189
06947462401751
GUDID
16947462494286
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000005694
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No