Identity
- Trade Name
- EasyScreen EUDAMED
- Device Name
- EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001) EUDAMED
- Model / Reference
- PE001H-MT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09351179001505 EUDAMED
- Basic UDI-DI
- B-09351179001505 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
EasyScreen by Genetic Signatures Ltd — 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-09351179001505 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genetic Signatures Ltd
- EUDAMED SRN
- AU-MF-000030901
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED df6c8e67-5d6c-47b6-b87d-9ef8d45163b7 61 fields · synced May 23, 2026