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ImmunoCAP Rare Allergen m201, Tilletia tritici (Ustilago tritici)
EUDAMEDClass B (EU MDR)
Ref 14-5029-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Rare Allergen m201, Tilletia tritici (Ustilago tritici) EUDAMED
- Device Name
- ImmunoCAP Allergen EUDAMED
- Model / Reference
- 14-5029-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066006192 EUDAMED
- Basic UDI-DI
- 7333066BUDI0018LZ EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 Rare Allergen m201, Tilletia tritici (Ustilago tritici) by Phadia AB — 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 | 7333066BUDI0018LZ | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED 86190575-85c1-4b2f-8c5f-1b770083e6a8 61 fields · synced Jun 19, 2026