Identity
- Trade Name
- EasyScreen™ Sample Processing Kit EUDAMED
- Device Name
- EasyScreen™ Sample Processing Kit EUDAMED
- Model / Reference
- SP012-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09351179000256 EUDAMED
- Basic UDI-DI
- 93511790SP012L7 EUDAMED
- EMDN Code
- W0105900103 SUPPLEMENTAL NA REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
New Device
No
EUDAMED
EasyScreen™ Sample Processing Kit by Genetic Signatures Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 93511790SP012L7 | Class A | 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 e5dd21f0-c057-497a-a69d-d3fc89658d12 61 fields · synced May 22, 2026