Identity
- Trade Name
- Electrolyte Analyzer EUDAMEDBIOBASE FDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- Electrolyte Analyzer EUDAMED
- Model / Reference
- BS006 EUDAMEDBKE-D FDA UDIBKE-A FDA UDIBKE-B FDA UDIBKE-C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936895300274 EUDAMEDFDA UDI06936895300281 EUDAMEDFDA UDI06936895300267 EUDAMEDFDA UDI06936895300250 EUDAMEDFDA UDI
- Basic UDI-DI
- 6936895BS0062C EUDAMED
- FDA Product Code
- JJP FDA UDI
- EMDN Code
- W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMEDW0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS EUDAMED
- GMDN Term
- Ion-selective analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 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
Electrolyte 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 | 6936895BS0062C | 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 (12)
- EUDAMED 013f55c9-58cf-48d4-98fc-4c67a995ff3c 61 fields · synced Oct 5, 2026
- EUDAMED d9fa178d-bfec-4c16-be17-df201c186821 61 fields · synced May 17, 2026
- EUDAMED c3da4fe4-9228-4429-86a4-3b50a42d7da9 61 fields · synced May 19, 2026
- EUDAMED de2e8a64-f32d-40f9-b700-b497a724d2e8 61 fields · synced May 19, 2026
- FDA UDI 67900443-faeb-4a15-974e-3d764e332b6a 32 fields · synced May 30, 2026
- FDA UDI 95c54ae0-eab3-46c1-afc4-b7de7574d0e4 32 fields · synced May 30, 2026
- FDA UDI a07e9c11-ab4f-4cd9-9a63-4222920c8629 32 fields · synced May 30, 2026
- FDA UDI a7d0c7fd-f386-4c80-ac80-fe71a5d7ba63 32 fields · synced May 30, 2026
- EUDAMED 915a76ff-596f-4f6e-b823-cdb9391e4843 61 fields · synced Jul 11, 2026
- EUDAMED 943b6fc0-b6c3-4b46-bbcf-a5e2820c3efd 61 fields · synced Jul 14, 2026
- EUDAMED f6f5b981-6c7a-4a41-8c0c-daf07b759968 61 fields · synced Jul 16, 2026
- EUDAMED 0690d9ab-84cc-4d1e-818f-1beea5f40831 61 fields · synced Oct 5, 2026