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Cisova®
EUDAMEDClass IVD General (EU MDR)
Ref 48 tests/kitRef 12 tests/kitRef 24 tests/kit
Identity
- Trade Name
- CISOVA® EUDAMED
- Device Name
- Human CDO1 and HOXA9 Gene Methylation Detection kit（Real-time PCR） EUDAMED
- Model / Reference
- 48 tests/kit EUDAMED12 tests/kit EUDAMED24 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975139678229 EUDAMED06975139678205 EUDAMED06975139678212 EUDAMED
- Basic UDI-DI
- B-06975139678229 EUDAMEDB-06975139678205 EUDAMEDB-06975139678212 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Cisova® by Beijing OriginPoly Bio-Tec 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-06975139678229 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing OriginPoly Bio-Tec Co., Ltd.
- EUDAMED SRN
- CN-MF-000043242
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 529960ae-e62f-43ad-b926-7f20c00a38ec 61 fields · synced Aug 2, 2026
- EUDAMED b3ead90f-3a23-4235-87fe-0ce048b7fa1b 61 fields · synced May 18, 2026
- EUDAMED 9a6f7078-2c8a-4f19-9aba-96a8f91e2ca6 61 fields · synced May 19, 2026