Identity
- Device Name
- Allergen Discs Aal EUDAMED
- Model / Reference
- 37106055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260153752645 EUDAMED
- Basic UDI-DI
- B-04260153752645 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Allergen Discs Aal is a medical device designed to detect and measure allergens in the air, providing accurate and reliable results for diagnostic purposes. Developed by Gold Standard Diagnostics Kassel GmbH, this device has undergone extensive testing and evaluation to ensure its performance meets stringent regulatory standards.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04260153752645 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
- EUDAMED SRN
- DE-MF-000021646
Sources (1)
- EUDAMED ccd4769f-30ac-4e95-a21e-0d00d3e6481a 61 fields · synced Jul 28, 2026