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Hemoglobin Control Solution
EUDAMEDClass IVD General (EU MDR)
Ref BA-231-1Model HC-201Ref BA-131-1Model HC-101
Identity
- Trade Name
- Hemoglobin Control Solution EUDAMED
- Device Name
- Hemoglobin Control Solution EUDAMED
- Model / Reference
- HC-201 EUDAMEDBA-231-1 EUDAMEDHC-101 EUDAMEDBA-131-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519631349 EUDAMED06975519630595 EUDAMED
- Basic UDI-DI
- B-06975519631349 EUDAMEDB-06975519630595 EUDAMED
- EMDN Code
- W0103010606 HAEMATOLOGY CONTROLS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMEDNetherlands 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 Control Solution 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-06975519631349 | 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 (2)
- EUDAMED 090163a9-d81d-47f2-acd5-edc81e21774c 61 fields · synced Jul 28, 2026
- EUDAMED a17a5d2d-a498-4f02-a60b-786d64814650 61 fields · synced May 17, 2026