Identity
- Trade Name
- BIOTIME EUDAMED
- Device Name
- CLi-1600 Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- CLi-1600 EUDAMEDBT0000401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260211388 EUDAMED
- Basic UDI-DI
- 69332602IT01000059Z EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Biotime by Xiamen Biotime Biotechnology Co., Ltd. — Class A — CE/MDR — 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 | 69332602IT01000059Z | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED b952fccb-79ba-405a-a321-f34228964ee5 61 fields · synced Oct 6, 2026
- EUDAMED cd7aed8f-12e7-454c-906c-afd73f3e0d33 61 fields · synced Jul 19, 2026