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Hemoglobin Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref HS-101
Identity
- Trade Name
- Hemoglobin Test Strip EUDAMED
- Device Name
- Hemoglobin Test Strip EUDAMED
- Model / Reference
- HS-101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663973106 EUDAMED
- Basic UDI-DI
- B-06939663973106 EUDAMED
- EMDN Code
- W0103010601 HAEMOGLOBIN (HB) 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
No
EUDAMED
Hemoglobin Test Strip 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-06939663973106 | 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 (1)
- EUDAMED 9efbcf8b-c60c-4628-8381-e35a57c17236 61 fields · synced Jun 19, 2026