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Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR)

by Hangzhou Bioer Technology Co., Ltd. 3 variants

Ref BSJ05S1Model BSJ05S1, BSJ05M1, BSJ05L1

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697384322BSJ05JJ Basic UDI-DI 06973843227900UDI-DIDate4 Dec 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  • Withdrawn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

Device Name
Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT-PCR)
Model / Reference
BSJ05S1, BSJ05M1, BSJ05L1
Primary DI / UDI-DI
06973843227900
Basic UDI-DI
697384322BSJ05JJ
Direct Marketing DI
06973843227900
EMDN Code
W0105040505 Respiratory syncytial virus (rsv) - na reagents
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019512
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Bioer Technology Co., Ltd.

See all devices from Hangzhou Bioer Technology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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