Identity
- Device Name
- careSTART™ Hb1 Analyzer EUDAMED
- Model / Reference
- BHN-E00182 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809446082135 EUDAMED
- Basic UDI-DI
- 880944608BAH0X0DW EUDAMED
- EMDN Code
- W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
careSTART™ Hb1 Analyzer by Wells Bio, Inc. — 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 | 880944608BAH0X0DW | Class A | Active |
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Manufacturer
- Manufacturer
- Wells Bio, Inc.
- EUDAMED SRN
- KR-MF-000031789
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 77ccc668-b54e-4ede-9c4d-210c9b00fbc6 61 fields · synced Jul 17, 2026