Identity
- Trade Name
- IDS Calprotectin Control Set EUDAMED
- Device Name
- IDS Calprotectin EUDAMED
- Model / Reference
- IS-AI26030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169696303 EUDAMED
- Basic UDI-DI
- 05060169696280HR EUDAMED5060169696280Y7 EUDAMED
- EMDN Code
- W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMEDW0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium 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
IDS Calprotectin Control Set by Immunodiagnostic Systems Limited — 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 | 05060169696280HR | Class B | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED 74f78f78-f897-46a0-bbf3-c4c6ca5e52be 61 fields · synced Jun 18, 2026
- EUDAMED 1769a735-8ff7-47bf-9e66-8a78b9e52ee9 61 fields · synced Jun 18, 2026