Identity
- Trade Name
- Automatic ELISA Processor EUDAMEDBIOBASE FDA UDI
- Generic Name
- Microplate reader IVD, automated/semi-automated FDA UDI
- Device Name
- Automatic ELISA Processor EUDAMED
- Model / Reference
- BS001 EUDAMEDBIOBASE8001 FDA UDIBIOBASE2001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674861300 EUDAMEDFDA UDI06971674861270 EUDAMEDFDA UDI
- Basic UDI-DI
- 6936895BS00122 EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W02010399 INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microplate reader IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Automatic ELISA Processor by Biobase Biodustry(Shandong) Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6936895BS00122 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (6)
- EUDAMED e6275038-0866-46be-9fa0-cbcdbe82aaed 61 fields · synced Jul 15, 2026
- EUDAMED 488bb7eb-34d7-4cf2-be57-d53af5f68219 61 fields · synced May 17, 2026
- FDA UDI ddde28a3-e2f1-4f7b-addc-79ec0a1bb6c3 32 fields · synced May 30, 2026
- FDA UDI 777b68ab-aa56-4af9-8034-7ae2b7fa93cc 32 fields · synced May 30, 2026
- EUDAMED 0a9fe782-f536-4c74-bc7e-2298e3e8b224 61 fields · synced Jul 15, 2026
- EUDAMED 19324e94-231b-4bdd-8f08-20a01d13d585 61 fields · synced Jul 15, 2026