Identity
- Trade Name
- CISVECO® EUDAMED
- Device Name
- Vaginitis Pathogens Multiplex Nucleic Acid Combined Detection Kit(Multiplex PCR Fluorescence Melting Curve Method) EUDAMED
- Model / Reference
- 48 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975139678250 EUDAMED
- Basic UDI-DI
- B-06975139678250 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-06975139678250 | 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 (1)
- EUDAMED a24d453c-f2cd-4239-9ae7-0debc9388263 61 fields · synced Jun 17, 2026