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Sharay Anti-sp100 IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18122001 Ref 14000755
Identity
- Trade Name
- Sharay Anti-sp100 IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-sp100 IgG (CLIA) EUDAMED
- Model / Reference
- 18122001 EUDAMED14000755 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761424 EUDAMED06975070769505 EUDAMED
- Basic UDI-DI
- B-06975070761424 EUDAMEDB-06975070769505 EUDAMED
- EMDN Code
- W0102100706 SP 100 ANTIBODIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
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-sp100 IgG (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-06975070761424 | 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 69e62ad2-3f5c-4e59-b528-8cef58156f89 61 fields · synced Jul 17, 2026
- EUDAMED c9d39ee5-e638-408b-bbdd-6ad1af24e312 61 fields · synced Jul 14, 2026
- EUDAMED 6c035d11-201d-4dab-9599-caa1c868f585 61 fields · synced Jul 17, 2026