Identity
- Trade Name
- IFA IgM FITC-CONJUGATE EUDAMED
- Model / Reference
- C0004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436040325131 EUDAMED
- Basic UDI-DI
- 843604032C000401DP EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
IFA IgM FITC-CONJUGATE by Vircell, S.L — 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 | 843604032C000401DP | Class A | Active |
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Manufacturer
- Manufacturer
- Vircell, S.L
- EUDAMED SRN
- ES-MF-000004099
Sources (1)
- EUDAMED 878acacd-0af9-46c1-825c-6f707d8baf96 61 fields · synced Jul 9, 2026