Allergen Discs r-Alt a 1 (Alternaria ten)

EUDAMED

Class IVD General (EU MDR)

Ref 37124909

by Gold Standard Diagnostics Kassel GmbH

Identity

Device Name: Allergen Discs r-Alt a 1 (Alternaria ten) EUDAMED
Model / Reference: 37124909 EUDAMED

Identifiers

Primary DI / UDI-DI: 04260153756223 EUDAMED
Basic UDI-DI: B-04260153756223 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

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Allergen Discs r-Alt a 1 (Alternaria ten) by Gold Standard Diagnostics Kassel GmbH — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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-04260153756223	Class IVD General	Active

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Manufacturer

Manufacturer: Gold Standard Diagnostics Kassel GmbH
EUDAMED SRN: DE-MF-000021646

Sources (1)

EUDAMED 8a24b0cc-c861-4204-a315-4d65b3ead047 61 fields · synced Jun 18, 2026