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Sharay KL-6 (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18124001 Model 100 Tests/kitRef 18124002
Identity
- Trade Name
- Sharay KL-6 (CLIA) EUDAMED
- Device Name
- Sharay KL-6 (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18124001 EUDAMED18124002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761585 EUDAMED06975070767808 EUDAMED
- Basic UDI-DI
- B-06975070761585 EUDAMEDB-06975070767808 EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMEDW01021299 ORGAN FUNCTION ASSAYS - OTHER 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 KL-6 (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-06975070761585 | 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 7cef19b0-7b05-4414-9470-4de312a2fc5a 61 fields · synced Jul 13, 2026
- EUDAMED 13ca020c-524d-4e7c-95d0-f81ee00beaff 61 fields · synced Jun 18, 2026
- EUDAMED c43e770c-0b89-4b0b-9860-1afecdf6bfd5 61 fields · synced Jul 13, 2026