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Hemoglobin Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref 5800SModel H7-1Ref 5800Model H7-2
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Device Name
- Hemoglobin Analyzer EUDAMED
- Model / Reference
- H7-1 EUDAMED5800S EUDAMEDH7-2 EUDAMED5800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535126 EUDAMED06934822535133 EUDAMED
- Basic UDI-DI
- B-06934822535126 EUDAMEDB-06934822535133 EUDAMED
- EMDN Code
- W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Hemoglobin Analyzer by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06934822535126 | 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 (2)
- EUDAMED d876d81a-e529-44b4-b9d0-47184fd2fdf4 61 fields · synced Jul 18, 2026
- EUDAMED 5d864b9a-f77b-4edb-97fa-bd8a16f07ec2 61 fields · synced May 18, 2026