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Hemoglobin Testing System
EUDAMEDClass IVD General (EU MDR)
Ref BC-211-1Model BC-202Ref BC-221-1Model BC-201、BC-202、BC-203Ref BC-111-1Model BC-102Ref BC-201-1Ref BC-101-1Model BC-101
Identity
- Trade Name
- Hemoglobin Testing System EUDAMED
- Device Name
- Hemoglobin Testing System EUDAMED
- Model / Reference
- BC-202 EUDAMEDBC-211-1 EUDAMEDBC-201、BC-202、BC-203 EUDAMEDBC-221-1 EUDAMEDBC-102 EUDAMEDBC-111-1 EUDAMEDBC-201-1 EUDAMEDBC-101 EUDAMEDBC-101-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519631172 EUDAMED06975519631493 EUDAMED06975519630052 EUDAMED06975519631165 EUDAMED06975519630038 EUDAMED
- Basic UDI-DI
- B-06975519631172 EUDAMED6975519630005B5Q EUDAMEDB-06975519630052 EUDAMEDB-06975519630038 EUDAMED
- Direct Marketing DI
- 06975519631493 EUDAMED
- EMDN Code
- W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain EUDAMEDFrance EUDAMEDRomania 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMEDEUDAMED
Hemoglobin Testing System by Hangzhou Bosure Biotech Co., Ltd — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975519631172 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975519631172 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bosure Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000003001
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (5)
- EUDAMED 168ff767-4aa4-4bd4-89e1-ffc112a01b15 61 fields · synced Jul 21, 2026
- EUDAMED ee39a139-7ce8-402b-a947-0c21fe34d57c 61 fields · synced May 18, 2026
- EUDAMED 03aa0187-0676-4b10-ae09-5079adc049de 61 fields · synced May 18, 2026
- EUDAMED 2c2ce86a-1a61-4ef2-81af-a06f05f78766 61 fields · synced May 18, 2026
- EUDAMED 14bae28a-f2cf-4fe6-bc2f-c91c3a373c34 61 fields · synced May 19, 2026