Identity
- Trade Name
- EasyScreen EUDAMEDEasyScreen™ Gastrointestinal Parasite Detection Kit FDA UDI
- Generic Name
- Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- EasyScreen™ Gastrointestinal Parasite Detection Kit EUDAMEDThe EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea. FDA UDI
- Model / Reference
- EP005-HT EUDAMED1 FDA UDI
- Description
- The EasyScreen™ Gastrointestinal Parasite Detection Kit is intended for use as an aid in the diagnosis of gastrointestinal illness by qualitative detection of Gastrointestinal Parasites from stool of patients with diarrhoea. FDA UDI
Identifiers
- Catalog Number
- EP005-HT FDA UDI
- Primary DI / UDI-DI
- 09351179001161 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09351179001161 EUDAMED
- 510(k) Number
- K232672 FDA UDI
- EMDN Code
- W01050704 MULTIPLE PARASITES PANELS EUDAMED
- GMDN Term
- Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
EasyScreen by Genetic Signatures Ltd — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-09351179001161 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Genetic Signatures Ltd
- EUDAMED SRN
- AU-MF-000030901
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 7ab55b18-9515-4c95-b4df-72cc94ba1e86 61 fields · synced Jul 19, 2026
- FDA UDI 765c6820-4711-413d-bb34-8f7f9180b620 37 fields · synced May 30, 2026