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Hemoglobin Monitoring meter
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HB-101,HB-201,HB-202Model HB-101.HB-201,HB-202
Identity
- Trade Name
- Hemoglobin Monitoring meter EUDAMED
- Device Name
- Hemoglobin Monitoring meter EUDAMED
- Model / Reference
- HB-101.HB-201,HB-202 EUDAMEDHB-101,HB-201,HB-202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663973007 EUDAMED
- Basic UDI-DI
- B-06939663973007 EUDAMED
- EMDN Code
- W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing 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
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Hemoglobin Monitoring meter by Sejoy Biomedical Co., Ltd. — Class IVD devices for self-testing — 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-06939663973007 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 16a843ba-2948-451f-b8dd-21590863fe8f 61 fields · synced Jun 18, 2026
- EUDAMED 16a843ba-2948-451f-b8dd-21590863fe8f-1 61 fields · synced Jun 10, 2026