← Back to catalogue
Dry Chemistry Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref CC-101-1Model CA-101
Identity
- Trade Name
- Dry Chemistry Analyzer EUDAMED
- Device Name
- Dry Chemistry Analyzer EUDAMED
- Model / Reference
- CA-101 EUDAMEDCC-101-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519630953 EUDAMED
- Basic UDI-DI
- B-06975519630953 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Dry Chemistry Analyzer by Hangzhou Bosure Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975519630953 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Bosure Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000003001
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 22dfb164-97cf-4a89-aabb-41bc34b090b4 61 fields · synced Jun 19, 2026