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Hemoglobin control
EUDAMEDClass IVD General (EU MDR)
Ref Level HModel HBC-3A
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- Hemoglobin control EUDAMED
- Model / Reference
- HBC-3A EUDAMEDLevel H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535553 EUDAMED
- Basic UDI-DI
- B-06934822535553 EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Hemoglobin control by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06934822535553 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 65b28be5-0c8e-4eae-8027-26d198be20ae 61 fields · synced Oct 6, 2026