Identity
- Device Name
- FIA Analyzer BIOT-YG-I EUDAMED
- Model / Reference
- BIOT-YG-I EUDAMEDBT0104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260209088 EUDAMED
- Basic UDI-DI
- 69332602IT01000049X 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
Yes
EUDAMEDEUDAMED
FIA Analyzer BIOT-YG-I by Xiamen Biotime 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 | 69332602IT01000049X | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f15c1410-5172-46cf-9d5a-6be9e2e5bac2 61 fields · synced Oct 7, 2026
- EUDAMED 91186d51-023a-46f4-8389-65649d924ec0 61 fields · synced Jul 9, 2026