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Sharay Anti-CENP-B IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18109001 Ref 14000726
Identity
- Trade Name
- Sharay Anti-CENP-B IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-CENP-B IgG (CLIA) EUDAMED
- Model / Reference
- 18109001 EUDAMED14000726 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070760977 EUDAMED06975070769376 EUDAMED
- Basic UDI-DI
- B-06975070760977 EUDAMEDB-06975070769376 EUDAMED
- EMDN Code
- W0102100115 ANTI-CENTROMERE 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-CENP-B 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-06975070760977 | 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 4f080320-676c-4fc0-ae2a-648a00ff9e4f 61 fields · synced Jul 17, 2026
- EUDAMED f86c93e2-36e0-4c51-8542-008987b393f6 61 fields · synced Jul 13, 2026
- EUDAMED deade4a4-3f26-4528-91b4-d1011ae2bb4e 61 fields · synced Jul 17, 2026