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Diagnostic Kit for Quantification of Neisseria Gonorrhoeae (PCR-Fluorescence Pr…
EUDAMEDClass IVD General (EU MDR)
Ref DA0062Model Single tube, 20 tests/kitRef DA0061
Identity
- Device Name
- Diagnostic Kit for Quantification of Neisseria Gonorrhoeae (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- Single tube, 20 tests/kit EUDAMEDDA0062 EUDAMEDDA0061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103000625 EUDAMED06928103000618 EUDAMED
- Basic UDI-DI
- B-06928103000625 EUDAMEDB-06928103000618 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
Yes
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
Diagnostic Kit for Quantification of Neisseria Gonorrhoeae (PCR-Fluorescence Pr… by Daan Gene 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-06928103000625 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 21e9b176-bcae-41a2-9b8f-60aa55b6aa4b 61 fields · synced Oct 6, 2026
- EUDAMED 6d32c4c3-9a37-4548-ac4b-4d51a3aadd2d 61 fields · synced May 17, 2026