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BioIC Allergen Specific-IgE Detection Kit
EUDAMEDClass B (EU MDR)
Ref AP40Model AD 40 series/ AP 40 series/ A7A series
Identity
- Trade Name
- BioIC Allergen Specific-IgE Detection Kit EUDAMED
- Device Name
- BioIC Allergen Specific-IgE Detection Kit EUDAMED
- Model / Reference
- AD 40 series/ AP 40 series/ A7A series EUDAMEDAP40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892991155 EUDAMED
- Basic UDI-DI
- 471989299Allergy8G EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland 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
BioIC Allergen Specific-IgE Detection Kit by Agnitio Science &technology, Inc. — 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 | 471989299Allergy8G | Class B | Active |
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Manufacturer
- Manufacturer
- Agnitio Science &technology, Inc.
- EUDAMED SRN
- TW-MF-000040942
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 44e8c441-f74c-47ba-9211-c56031463cfc 61 fields · synced Jun 19, 2026