Identity
- Trade Name
- ISE CALIBRATORS EUDAMED
- Device Name
- ISE CALIBRATORS EUDAMED
- Model / Reference
- ISCA-4222 EUDAMEDISCA-4221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700824022 EUDAMED03701700824015 EUDAMED
- Basic UDI-DI
- 37017008ISCA049C EUDAMED
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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 Calibrators by Vitalscientific — Class B — 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 | 37017008ISCA049C | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED df2af65e-e04c-4834-9ce1-243ea1ac0972 61 fields · synced Jul 12, 2026
- EUDAMED 3ea6d6f8-d651-4afd-8d55-a386dcebbff6 61 fields · synced May 17, 2026