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Sharay Anti-Trophoblast Cell Membrane (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18412001 Ref 14000777
Identity
- Trade Name
- Sharay Anti-Trophoblast Cell Membrane (CLIA) EUDAMED
- Device Name
- Sharay Anti-Trophoblast Cell Membrane (CLIA) EUDAMED
- Model / Reference
- 18412001 EUDAMED14000777 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762049 EUDAMED06980070460055 EUDAMED
- Basic UDI-DI
- B-06975070762049 EUDAMEDB-06980070460055 EUDAMED
- EMDN Code
- W0102050199 FERTILITY FUNCTION HORMONES - OTHER EUDAMEDW0102050299 PREGNANCY TESTING HORMONES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Sharay Anti-Trophoblast Cell Membrane (CLIA) by C-Luminary Biotechnology 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-06975070762049 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 1b1c0faf-045c-42d6-95e3-b14eb12b690b 61 fields · synced Jul 30, 2026
- EUDAMED 24fbac8d-52e7-4c89-85bf-685068a1bf36 61 fields · synced Jul 18, 2026
- EUDAMED 2580a5a2-c18b-4d8b-a620-26f6c1d1ca0b 61 fields · synced Jul 30, 2026