Identity
- Trade Name
- EasyScreen EUDAMED
- Device Name
- EasyScreen Respiratory Pathogen Detection Kit (RP007) EUDAMED
- Model / Reference
- RP007-HT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09351179002021 EUDAMED
- Basic UDI-DI
- B-09351179002021 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT 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-09351179002021 | 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 7c57f0be-610b-4c13-b9f5-e3e05a34d9e5 61 fields · synced May 23, 2026