← Back to catalogue
Breath Alcohol Detector
EUDAMEDClass IVD General (EU MDR)
Ref AC-101-1Model AC-101
Identity
- Trade Name
- Breath Alcohol Detector EUDAMED
- Device Name
- Breath Alcohol Detector EUDAMED
- Model / Reference
- AC-101 EUDAMEDAC-101-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975519631094 EUDAMED
- Basic UDI-DI
- B-16975519631094 EUDAMED
- EMDN Code
- W01010699 CLIN. CHEM. RT & POC - 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Breath Alcohol Detector 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-16975519631094 | 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 107b528d-e610-4aac-9875-d75718e22b0a 61 fields · synced Jul 25, 2026