Identity
- Trade Name
- Hemoglobin Analysis Meter EUDAMED
- Device Name
- Hemoglobin Analysis Meter EUDAMED
- Model / Reference
- BHM-202 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971771209005 EUDAMED
- Basic UDI-DI
- 69717712090059P EUDAMED
- EMDN Code
- W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
New Device
No
EUDAMED
Hemoglobin Analysis Meter by Hangzhou Lysun Biotechnology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69717712090059P | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 8d5f3ab3-badc-4b02-b24b-6d26f87059e2 61 fields · synced Jun 18, 2026