← Back to catalogue
Sharay APS IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18156001 Ref 18516001Ref 14000781
Identity
- Trade Name
- Sharay APS IgG (CLIA) EUDAMED
- Device Name
- Sharay APS IgG (CLIA) EUDAMED
- Model / Reference
- 18156001 EUDAMED18516001 EUDAMED14000781 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762360 EUDAMED06980070460062 EUDAMED
- Basic UDI-DI
- B-06975070762360 EUDAMEDB-06980070460062 EUDAMED
- EMDN Code
- W0102100502 ANTI-PHOSPHATIDYLSERIN ANTIBODIES EUDAMEDW0102100599 ANTI-PHOSPHOLIP SYNDROME - 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 APS 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-06975070762360 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED aedb55f6-3511-4747-b92d-1049ff6da3a4 61 fields · synced Jul 19, 2026
- EUDAMED 166d79cd-4526-4110-aa31-0559281a35d7 61 fields · synced Jun 18, 2026
- EUDAMED 16b47772-b4ed-4d87-90b7-1fe91df239e6 61 fields · synced Jul 19, 2026