Identity
- Trade Name
- HYDRASYS 2 SCAN FOCUSING EUDAMED
- Device Name
- HYDRASYS 2 SCAN FOCUSING EUDAMED
- Model / Reference
- 1202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607360012024 EUDAMED
- Basic UDI-DI
- 3607361202BUAV EUDAMED
- EMDN Code
- W020105010201 SEMI-AUTOMATED ELECTROPHORESIS SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Hydrasys 2 Scan Focusing by Sebia — 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 | 3607361202BUAV | Class A | Active |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (2)
- EUDAMED 2a6b999e-8717-4d30-b63b-f8221e674c94 61 fields · synced Jun 18, 2026
- EUDAMED 52ebde25-931d-4a83-be0f-d119107b820f 61 fields · synced Jun 18, 2026