Identity
- Trade Name
- cPass EUDAMED
- Device Name
- cPass SARS-CoV-2 Neutralization Antibody Detection Kit EUDAMED
- Model / Reference
- L00847 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975379900036 EUDAMED
- Basic UDI-DI
- B-06975379900036 EUDAMED
- EMDN Code
- W0105040519 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
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
cPass by Nanjing Genscript Diagnostics Technology Co., Ltd. — 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-06975379900036 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing Genscript Diagnostics Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025148
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 3eccbf4f-78c3-4178-a71d-db3db9181ac6 61 fields · synced Jul 13, 2026