← Back to catalogue
Semi-auto Chemistry Analyzer
EUDAMEDFDA UDIClass A (EU MDR)
Ref BS002Model Biobase-SilverRef BIOBASE-Claire
Identity
- Trade Name
- Semi-auto Chemistry Analyzer EUDAMEDBIOBASE FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Semi-auto Chemistry Analyzer EUDAMED
- Model / Reference
- Biobase-Silver EUDAMEDBS002 EUDAMEDBIOBASE-Claire EUDAMEDBiobaseSilver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936895300151 EUDAMEDFDA UDI06936895304562 EUDAMED
- Basic UDI-DI
- 6936895BS00224 EUDAMED
- FDA Product Code
- JJQ FDA UDI
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2300 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
Semi-auto Chemistry Analyzer 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 | 6936895BS00224 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (4)
- EUDAMED 4ec751d5-f39d-4c59-9f64-ee70095ff733 61 fields · synced Oct 6, 2026
- FDA UDI a6761eeb-c096-4a19-936d-c58f3a05f67f 32 fields · synced May 29, 2026
- EUDAMED 028d3f12-7104-4fcc-a607-d7ab6d8bd1fd 61 fields · synced Jul 11, 2026
- EUDAMED cc19830b-3f25-4959-9f6a-d591543c0095 61 fields · synced Jul 24, 2026