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Automatic chemistry analyzer
EUDAMEDClass A (EU MDR)
Ref Spin XLModel Spin XS， Spin XL ， Spin XT
Identity
- Trade Name
- Automatic chemistry analyzer EUDAMED
- Device Name
- Automatic Chemistry Analyzer EUDAMED
- Model / Reference
- Spin XS， Spin XL ， Spin XT EUDAMEDSpin XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936895302841 EUDAMED
- Basic UDI-DI
- 69368953028ACA-Spin**38 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Automatic chemistry analyzer by Biobase Biodustry(Shandong) 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 | 69368953028ACA-Spin**38 | Class A | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED bb4f2360-39ec-4395-9d25-880bf15697f2 61 fields · synced Jun 18, 2026