Identity
- Trade Name
- ISE CLEANER/CONDITIONER EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- ISE CLEANER/CONDITIONER EUDAMED
- Model / Reference
- ISCC-0280 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540215407 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540ISCC00NR 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
No
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 | 3661540ISCC00NR | 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 (2)
- EUDAMED a3c61d33-5760-4d38-ae53-33e0a3f789a6 61 fields · synced Jun 18, 2026
- FDA UDI 9212a113-6fb1-4568-a7df-98f59a79b540 32 fields · synced May 30, 2026