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ImmunoCAP Specific IgA/IgG Sample Diluent
EUDAMEDClass A (EU MDR)
Ref 10-9361-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Specific IgA/IgG Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- 10-9361-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066011677 EUDAMED
- Basic UDI-DI
- 7333066BUDI0040LS EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A 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
ImmunoCAP Specific IgA/IgG Sample Diluent by Phadia AB — Class A — 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 | 7333066BUDI0040LS | Class A | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED 8e11673b-789b-4acb-8b42-3339f7913e07 61 fields · synced Jun 18, 2026