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EasyScreen
EUDAMEDClass IVD General (EU MDR)
Ref PE001G-MTRef PE001-MT Panel FRef PE001-HT Panel ARef EB001-HTRef PE001-MT Panel DRef PE001-MT Panel BRef PE001-MT Panel CRef EV002-HT
Identity
- Trade Name
- EasyScreen EUDAMED
- Device Name
- EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001) EUDAMEDEasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001 - Panel A) EUDAMEDEasyScreen® Enteric Bacteria Detection Kit EUDAMEDEasyScreen™ Pan-Enteric Pathogen Detection Kit EUDAMEDEasyScreen ® Pan Enteric Detection Kit PE001 Panel B EUDAMEDEasyScreen ® Pan Enteric Pathogen Detection Kit EUDAMEDEasyScreen ® Enteric Virus Detection Kit EUDAMED
- Model / Reference
- PE001G-MT EUDAMEDPE001-MT Panel F EUDAMEDPE001-HT Panel A EUDAMEDEB001-HT EUDAMEDPE001-MT Panel D EUDAMEDPE001-MT Panel B EUDAMEDPE001-MT Panel C EUDAMEDEV002-HT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09351179001475 EUDAMED09351179001420 EUDAMED09351179001222 EUDAMED09351179001024 EUDAMED09351179001345 EUDAMED09351179001260 EUDAMED09351179001307 EUDAMED09351179001086 EUDAMED
- Basic UDI-DI
- B-09351179001475 EUDAMEDB-09351179001420 EUDAMEDB-09351179001222 EUDAMEDB-09351179001024 EUDAMEDB-09351179001345 EUDAMEDB-09351179001260 EUDAMEDB-09351179001307 EUDAMEDB-09351179001086 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-09351179001475 | 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 (9)
- EUDAMED 82daaca8-1b34-4ca3-acfe-ba0e54ed69a2 61 fields · synced Jul 18, 2026
- EUDAMED 3464c255-2db9-4832-a5ac-a395a50c255c 61 fields · synced May 16, 2026
- EUDAMED 21b3d4e0-5dfc-409b-bf6c-c9a7c0219769 61 fields · synced May 17, 2026
- EUDAMED 6d2d9e52-0835-4393-b716-ad8f92413fb9 61 fields · synced May 17, 2026
- EUDAMED b293c02d-59cb-4b5f-92bf-0e06f4d51ff6 61 fields · synced May 18, 2026
- EUDAMED 6823a1e3-1aae-4143-8e0b-1979cd4786c4 61 fields · synced May 18, 2026
- EUDAMED d0004889-ade3-45ef-a8c3-a4c7ca6c1820 61 fields · synced May 18, 2026
- EUDAMED 9af3446c-2c91-4796-a1ff-a5b24f128542 61 fields · synced Jul 10, 2026
- EUDAMED 5cac05e9-8ae5-4ade-bb97-fbfde988b9b6 61 fields · synced Jul 13, 2026