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Sharay Anti-Spermatozoa IgM (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18403001 Ref 14000739
Identity
- Trade Name
- Sharay Anti-Spermatozoa IgM (CLIA) EUDAMED
- Device Name
- Sharay Anti-Spermatozoa IgM (CLIA) EUDAMED
- Model / Reference
- 18403001 EUDAMED14000739 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762018 EUDAMED06975070762520 EUDAMED
- Basic UDI-DI
- B-06975070762018 EUDAMEDB-06975070762520 EUDAMED
- EMDN Code
- W0102050199 FERTILITY FUNCTION 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
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
Sharay Anti-Spermatozoa IgM (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-06975070762018 | 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 b97f8af5-0742-4829-903d-f357c81868db 61 fields · synced Jul 9, 2026
- EUDAMED f855c9cd-96b8-42c3-be3c-ee546770c360 61 fields · synced Jun 19, 2026
- EUDAMED 785de2fb-fde4-4a15-b7b3-2178857ef5b4 61 fields · synced Jul 9, 2026