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Fully Automated CLIA Analyzer
EUDAMEDClass A (EU MDR)
Ref 19100002Model Sharay 1600
Identity
- Trade Name
- Fully Automated CLIA Analyzer EUDAMED
- Model / Reference
- Sharay 1600 EUDAMED19100002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975907932676 EUDAMED
- Basic UDI-DI
- 697590793CLSharay1600WE EUDAMED
- Direct Marketing DI
- 06975907932676 EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fully Automated CLIA Analyzer by C-Luminary Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697590793CLSharay1600WE | Class A | 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 (1)
- EUDAMED 6cad8ffc-532e-4f63-b3bc-030cad051197 61 fields · synced Jun 17, 2026