Identity
- Trade Name
- ISE CONDITIONER EUDAMED
- Device Name
- ISE CLEANER/CONDITIONER EUDAMED
- Model / Reference
- ISCO-5220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700824121 EUDAMED03661540215421 EUDAMED
- Basic UDI-DI
- 37017008ISCC009E EUDAMED3661540ISCC00NR EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES 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
No
EUDAMED
New Device
No
EUDAMED
Ise Conditioner by Vitalscientific — 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 | 37017008ISCC009E | Class A | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 5b8d0a91-a779-4d82-83cf-6e53055725bb 61 fields · synced Jul 15, 2026
- EUDAMED cf5e8196-0aab-4c74-ba56-4e3a6159b1e0 61 fields · synced May 16, 2026