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Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18512001Model 100 Tests/kitRef 18514001Ref 18511001Ref 18516001
Identity
- Trade Name
- Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-Phospholipid Syndrome Antibody Profile IgG (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18512001 EUDAMED18514001 EUDAMED18511001 EUDAMED18516001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762315 EUDAMED06975070762339 EUDAMED06975070762308 EUDAMED06975070762353 EUDAMED
- Basic UDI-DI
- B-06975070762315 EUDAMEDB-06975070762339 EUDAMEDB-06975070762308 EUDAMEDB-06975070762353 EUDAMED
- EMDN Code
- W0102100599 ANTI-PHOSPHOLIP SYNDROME - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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-Phospholipid Syndrome Antibody Profile IgG (CLIA) by C-Luminary Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975070762315 | 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 (4)
- EUDAMED eaaf5cb9-5b3c-46be-8024-e73da1ec6ce7 61 fields · synced Oct 6, 2026
- EUDAMED 94d5f631-3a23-4ecc-97d4-0471d05e7993 61 fields · synced May 17, 2026
- EUDAMED e1b8ad9a-89c5-49c8-9862-b006807f427f 61 fields · synced May 18, 2026
- EUDAMED 9bbdc106-fd6e-40e6-ad7e-aecaa262b6d9 61 fields · synced May 19, 2026