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Ise Cleaner/Conditioner
EUDAMEDFDA UDIClass A (EU MDR)
Ref ISCC-0280Ref ISCL-5080
Identity
- Trade Name
- ISE CLEANER/CONDITIONER EUDAMEDFDA UDIISE CLEANER EUDAMED
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- ISE CLEANER/CONDITIONER EUDAMED
- Model / Reference
- ISCC-0280 EUDAMEDFDA UDIISCL-5080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700824107 EUDAMEDFDA UDI03661540215414 EUDAMED
- Basic UDI-DI
- 37017008ISCC009E EUDAMED3661540ISCC00NR EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ise Cleaner/Conditioner by Vitalscientific — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008ISCC009E | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (3)
- EUDAMED 8c319dab-626e-4920-bac2-19220981dcff 61 fields · synced Jul 12, 2026
- EUDAMED baecd17e-64aa-4f35-af2b-df9bb41647bb 61 fields · synced May 19, 2026
- FDA UDI 7850cb61-e840-471b-97ef-ef1f9766bf12 32 fields · synced May 30, 2026