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Hemoglobin Test Strips
EUDAMEDClass IVD General (EU MDR)
Ref BS-101-1Model BS-101
Identity
- Trade Name
- Hemoglobin Test Strips EUDAMED
- Device Name
- Hemoglobin Test Strips EUDAMED
- Model / Reference
- BS-101 EUDAMEDBS-101-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519630014 EUDAMED
- Basic UDI-DI
- B-06975519630014 EUDAMED
- EMDN Code
- W0103010601 HAEMOGLOBIN (HB) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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
Hemoglobin Test Strips 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-06975519630014 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bosure Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000003001
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 4bb4082a-3032-4eb4-a703-3504835a1fe7 61 fields · synced Jun 18, 2026