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ImmunoCAP Allergen t201, Spruce
EUDAMEDClass B (EU MDR)
Ref 14-5005-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Allergen t201, Spruce EUDAMED
- Device Name
- ImmunoCAP Allergen EUDAMED
- Model / Reference
- 14-5005-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066005898 EUDAMED
- Basic UDI-DI
- 7333066BUDI0017LX 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
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
ImmunoCAP Allergen t201, Spruce by Phadia AB — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7333066BUDI0017LX | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED e527f2ec-51ab-4c38-8cc7-d0ac1323d446 61 fields · synced Jul 27, 2026