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Neisseria Gonorrhoea (NG) Nucleic Acid Detection Kit (Fluorescent PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 48 tests/kit
Identity
- Device Name
- Neisseria Gonorrhoea (NG) Nucleic Acid Detection Kit (Fluorescent PCR Method) EUDAMED
- Model / Reference
- 48 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221451180 EUDAMED
- Basic UDI-DI
- B-06972221451180 EUDAMED
- EMDN Code
- W0105010203 GONOCOCCAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Neisseria Gonorrhoea (NG) Nucleic Acid Detection Kit (Fluorescent PCR Method) by CapitalBio Technology (Chengdu) Co., Ltd. — Class IVD General — IVDD — listed…
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-06972221451180 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CapitalBio Technology (Chengdu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000027694
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 864647f3-7710-45ca-8e46-c536cfe56f16 61 fields · synced Jul 22, 2026