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Neisseria gonorrhoeae PCR kit (Form F)
EUDAMEDClass IVD General (EU MDR)
Ref 84-01Model Neisseria gonorrhoeae PCR kit
Identity
- Device Name
- Neisseria gonorrhoeae PCR kit (Form F) EUDAMED
- Model / Reference
- Neisseria gonorrhoeae PCR kit EUDAMED84-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251557100811 EUDAMED
- Basic UDI-DI
- B-04251557100811 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
Yes
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
Neisseria gonorrhoeae PCR kit (Form F) by Astra Biotech GmbH — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-04251557100811 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Astra Biotech GmbH
- EUDAMED SRN
- DE-MF-000026439
Sources (1)
- EUDAMED 7c7802ac-a198-4808-ab43-326638e31b7e 61 fields · synced Jul 8, 2026