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PCR-based Neisseria Gonorrhoeae Test Kit (Fluorometric PCR)
EUDAMEDClass IVD General (EU MDR)
Ref ID023
Identity
- Device Name
- PCR-based Neisseria Gonorrhoeae Test Kit (Fluorometric PCR) EUDAMED
- Model / Reference
- ID023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012962 EUDAMED
- Basic UDI-DI
- B-06974323012962 EUDAMED
- EMDN Code
- W0105010203 GONOCOCCAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
PCR-based Neisseria Gonorrhoeae Test Kit (Fluorometric PCR) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974323012962 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 7a32acdc-dd11-4270-92b8-5c83093678b6 61 fields · synced Jun 19, 2026