Identity
- Trade Name
- BSBE EUDAMED
- Device Name
- Potassium Assay Kit(K) (Pyruvate Kinase Method) EUDAMED
- Model / Reference
- ETGS4K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936736052454 EUDAMED
- Basic UDI-DI
- 69367360BSBE0002SU EUDAMED
- Direct Marketing DI
- 06936736052454 EUDAMED
- EMDN Code
- W01010308 POTASSIUM EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Bsbe by Beijing Strong Biotechnologies, Inc. — Class B — 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 | 69367360BSBE0002SU | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Strong Biotechnologies, Inc.
- EUDAMED SRN
- CN-MF-000004362
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d8f33e03-8d42-4292-b8c2-d25f198a5055 61 fields · synced Jun 18, 2026