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Streptococcus Group B antisera

by Genhawk (Wuhan) Biotech Co., Ltd. 10 variants

Ref Streptococcus Group B Type antisera（Type IV）

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-06977597620048 Basic UDI-DI 06977597620048UDI-DIDate9 Jul 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Streptococcus Group B antisera
Model / Reference
Streptococcus Group B Type antisera（Type IV）
Primary DI / UDI-DI
06977597620048
Basic UDI-DI
B-06977597620048
EMDN Code
W0105011101, W0105011102, W0105011103, W0105011104, W0105011105, W0105011199
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042707
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Genhawk (Wuhan) Biotech Co., Ltd.

See all devices from Genhawk (Wuhan) Biotech Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No