← Back to catalogue
Multi Biosensor Module
EUDAMEDClass A (EU MDR)
Ref 90101Model CBS-300, cbs-400, KS-401
Identity
- Trade Name
- Multi Biosensor Module EUDAMED
- Device Name
- Multi Biosensor Module EUDAMED
- Model / Reference
- CBS-300, cbs-400, KS-401 EUDAMED90101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337850136 EUDAMED
- Basic UDI-DI
- 697233785MBM008HX EUDAMED
- EMDN Code
- W01010803 MULTIPLE ELECTROLYTES ONLY - ELECTRODES/BIOSENSORS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Multi Biosensor Module by B&E Bio-Technology 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 | 697233785MBM008HX | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ffc7ea71-fb0d-4882-8349-7a780d4df217 61 fields · synced Jul 9, 2026