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Automatic Chemistry Analyzer
EUDAMEDFDA UDIClass A (EU MDR)
Ref BS003Ref BK-310Ref BK-2000
Identity
- Trade Name
- Automatic Chemistry Analyzer EUDAMEDBIOBASE FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- Automatic Chemistry Analyzer EUDAMED
- Model / Reference
- BS003 EUDAMEDBK-310 EUDAMEDBK-2000 EUDAMEDBK600 FDA UDIBK500 FDA UDIBK800 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674861218 EUDAMEDFDA UDI06936895300304 EUDAMEDFDA UDI06936895300298 EUDAMEDFDA UDI06936895302681 EUDAMED06936895302971 EUDAMED
- Basic UDI-DI
- 6936895BS00326 EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) EUDAMEDW0201010103 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200) EUDAMEDW0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMEDW0201010104 CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200) EUDAMED
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory 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 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 | 6936895BS00326 | 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 (11)
- EUDAMED 0e3a13c6-0a96-4728-ba37-d931aa94c48e 61 fields · synced Oct 6, 2026
- EUDAMED 60cdbfee-310d-4c33-8bca-2c4a8d71d37f 61 fields · synced May 19, 2026
- EUDAMED 2bb854dc-852a-42e5-be0d-510d0ff77ab8 61 fields · synced May 19, 2026
- FDA UDI 6d368657-cd1c-4848-83b7-d19df2e5c272 32 fields · synced May 30, 2026
- FDA UDI 067f7899-41f0-4d98-9438-61fab856a2b5 32 fields · synced May 30, 2026
- FDA UDI 42c90209-d6ee-4a09-9bab-1502c8a17f25 32 fields · synced May 30, 2026
- EUDAMED bedaa1ef-0849-47af-b346-457b4d938346 61 fields · synced Jun 19, 2026
- EUDAMED 4fc5769f-08ef-4846-a3ef-04aac683e235 61 fields · synced Jul 12, 2026
- EUDAMED bf36e1a4-4fa8-4016-b43a-3efe2cbdee57 61 fields · synced Jul 17, 2026
- EUDAMED a54f2ea9-81ee-4ee8-acac-2e1cca71dea5 61 fields · synced Jul 25, 2026
- EUDAMED 4e66a8a3-56f5-4b8c-a296-ce090c9a6237 61 fields · synced Aug 1, 2026