Identity
- Trade Name
- ImmunoCAP ISAC E Control EUDAMED
- Device Name
- ImmunoCAP ISAC E112i EUDAMED
- Model / Reference
- 81-1021-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066021140 EUDAMED
- Basic UDI-DI
- 7333066BUDI0035LZ EUDAMED
- EMDN Code
- W01020204 IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
ImmunoCAP ISAC E Control by Phadia AB — Class C — 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 | 7333066BUDI0035LZ | Class C | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED 85afbfbd-eda4-4d22-adeb-396e408deb44 61 fields · synced Jun 19, 2026