Identity
- Trade Name
- IGM IP EUDAMED
- Device Name
- IGM IP EUDAMED
- Model / Reference
- IIGM-6125 EUDAMEDIIGM-5025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700822615 EUDAMED03701700822622 EUDAMED
- Basic UDI-DI
- B-03701700822615 EUDAMEDB-03701700822622 EUDAMED
- EMDN Code
- W0102010108 IMMUNOGLOBULIN M SUBCLASS REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Igm Ip by Vitalscientific — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03701700822615 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 56a05ded-c797-4293-9125-837c95cc349e 61 fields · synced Jul 31, 2026
- EUDAMED 7d34d8e0-cf0f-4753-8ef2-7b3d01857c3e 61 fields · synced May 18, 2026