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AIA-PACK IgE SAMPLE DILUTING SOLUTION
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0020595
Identity
- Trade Name
- AIA-PACK IgEII Sample Diluting Solution FDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, reagent FDA UDI
- Device Name
- AIA-PACK IgE SAMPLE DILUTING SOLUTION EUDAMED
- Model / Reference
- 0020595 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211087 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189211087 EUDAMED
- FDA Product Code
- DGC FDA UDI
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
- GMDN Term
- Total immunoglobulin E (IgE total) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
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
Prescription Use
No
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
AIA-PACK IgE SAMPLE DILUTING SOLUTION by Tosoh Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04560189211087 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED 84c5cd94-bd87-4f0f-9a0c-a55cd89ed599 61 fields · synced Jun 18, 2026
- FDA UDI 3767f084-eeed-44e6-bdef-77f38447666f 34 fields · synced May 30, 2026