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Ciscer®
EUDAMEDClass IVD General (EU MDR)
Ref 48 tests/kitRef 12 tests/kit..Ref 24 tests/kit
Identity
- Trade Name
- CISCER® EUDAMED
- Device Name
- Human PAX1 and JAM3 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
- 06975139678168 EUDAMED06975139678144 EUDAMED06975139678151 EUDAMED
- Basic UDI-DI
- B-06975139678168 EUDAMEDB-06975139678144 EUDAMEDB-06975139678151 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
Ciscer® 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-06975139678168 | 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 b108ae6f-1b4e-42a7-9c72-ae753d052994 61 fields · synced Sep 17, 2026
- EUDAMED 805fc081-3d92-4e2a-b623-3ed26a681226 61 fields · synced May 18, 2026
- EUDAMED 9a6ad944-496e-467a-83b7-b9adf66ddc2e 61 fields · synced May 18, 2026