Identity
- Trade Name
- CISVECO® EUDAMED
- Device Name
- Vaginitis Pathogens Multiplex Nucleic Acid Combined Detection Kit (Multiplex PCR Fluorescence Melting Curve Method) EUDAMEDVaginitis Pathogens Multiplex Nucleic Acid Combined Detection Kit(Multiplex PCR Fluorescence Melting Curve Method) EUDAMED
- Model / Reference
- 12 tests/kit EUDAMED24 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975139678236 EUDAMED06975139678243 EUDAMED
- Basic UDI-DI
- B-06975139678236 EUDAMEDB-06975139678243 EUDAMED
- EMDN Code
- W0105070502 OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS 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
Cisveco® 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-06975139678236 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing OriginPoly Bio-Tec Co., Ltd.
- EUDAMED SRN
- CN-MF-000043242
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED c834af26-9b46-4527-9edc-af917e444417 61 fields · synced Jul 20, 2026
- EUDAMED c7356b59-4c71-455e-aa3d-d1fe2ce1e157 61 fields · synced May 17, 2026