Identity
- Trade Name
- IDS APS IgM Control Set EUDAMED
- Device Name
- IDS APS IgM Control Set EUDAMED
- Model / Reference
- IS-AI1630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169694194 EUDAMED
- Basic UDI-DI
- B-05060169694194 EUDAMED
- EMDN Code
- W0102152001 TDM/DRUG CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
IDS APS IgM Control Set by Immunodiagnostic Systems Limited — 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-05060169694194 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (1)
- EUDAMED c27e315b-2077-468c-8fd7-ecf3d11f1a3c 61 fields · synced Jul 13, 2026