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Methicillin-Resistant Staphylococcus aureus (MRSA) Nucleic Acid Detection Kit

by Hangzhou Zhunxin Biotechnology

Ref HA-016

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976037880080 Basic UDI-DI 06976037880080UDI-DIDate4 Sep 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Methicillin-Resistant Staphylococcus aureus (MRSA) Nucleic Acid Detection Kit
Model / Reference
HA-016
Primary DI / UDI-DI
06976037880080
Basic UDI-DI
B-06976037880080
EMDN Code
W0105011203 Staphylococcal detection by na reagents
Device Class
Class IVD Annex II List B
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000028333
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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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