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Specimen container

by Zhejiang Gongdong Medical Technology Co., Ltd., 18 variants

Ref GD4825-1, GD4834, D1001, GD4825, H1015, H1016, H1016-6, K1024, H1015G, GD4834-1G, H1016G, GD4825G, K1027GModel boric acid + sodium formate + sodium borate, No addition, faeces container, secretion container, human urine container, human secretion for culture container.

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6947462411111172M2 Basic UDI-DI Date17 Mar 2025RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
boric acid + sodium formate + sodium borate, GD4825-1, No addition, GD4834, D1001, GD4825, faeces container, secretion container, human urine container, human secretion for culture container., H1015, H1016, H1016-6, K1024, H1015G, GD4834-1G, H1016G, GD4825G, K1027G
Primary DI / UDI-DI
06947462433554, 06947462433608, 06947462436333, 06947462433592, 06947462433905, 06947462438801, 06947462491813, 06947462437743, 06947462437149, 06947462432045, 06947462438900, 06947462438948, 06947462438894, 06947462438979, 06947462438924
Basic UDI-DI
6947462411111172M2, 6947462411111173M4, 6947462411111219M3, 6947462411111161LV, 6947462411111193MA, 6947462411111225LW, 6947462411111227M2, 6947462411111228M4
EMDN Code
W05019099, W05019001
Device Class
Class A
EU market of registration
Germany
Romania
Poland
France

Manufacturer details

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

Other devices from Zhejiang Gongdong Medical Technology Co., Ltd.

See all devices from Zhejiang Gongdong Medical Technology Co., Ltd. →

Properties

  • Sterile

Other properties (10)

  • 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