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ImmunoCAP Dummy ImmunoCAP
EUDAMEDFDA UDIClass A (EU MDR)
Ref 14-4317-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Dummy ImmunoCAP EUDAMEDFDA UDI
- Generic Name
- Plasma protein IVD, reagent FDA UDI
- Device Name
- System Accessories EUDAMEDImmunoCAP Dummy ImmunoCAP FDA UDI
- Model / Reference
- 14-4317-01 EUDAMEDFDA UDI
- Description
- ImmunoCAP Dummy ImmunoCAP FDA UDI
Identifiers
- Catalog Number
- 14-4317-01 FDA UDI
- Primary DI / UDI-DI
- 07333066003023 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0023LS EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Plasma protein IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ImmunoCAP Dummy ImmunoCAP by Phadia AB — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0023LS | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED 2eb3abb5-868e-4f4a-8013-e2d0ea441137 61 fields · synced Jun 20, 2026
- FDA UDI a4320d3f-0eab-4da7-a523-565b91eb0073 36 fields · synced May 30, 2026