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Allergen Discs Helminthosporium halodes
EUDAMEDClass IVD General (EU MDR)
Ref 37113008
Identity
- Device Name
- Allergen Discs Helminthosporium halodes EUDAMED
- Model / Reference
- 37113008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260153755011 EUDAMED
- Basic UDI-DI
- B-04260153755011 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 Helminthosporium halodes by Gold Standard Diagnostics Kassel GmbH — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04260153755011 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
- EUDAMED SRN
- DE-MF-000021646
Sources (1)
- EUDAMED b7a7089d-99c1-4f60-94ef-1a1b70e294f9 61 fields · synced Jul 12, 2026