Identity
- Trade Name
- PreFoam Enzyme EUDAMED
- Device Name
- VZF EUDAMED
- Model / Reference
- J98TP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060722253424 EUDAMED
- Basic UDI-DI
- 506072225AAA0016JX EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Medical device disinfection agent
PreFoam Enzyme by Amity Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506072225AAA0016JX | Class I | Active |
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Manufacturer
- Manufacturer
- Amity Limited
- EUDAMED SRN
- GB-MF-000023321
- Authorised Representative
- Amity Healthcare EU Ltd. IE-AR-000011613
Sources (2)
- EUDAMED 47349a5b-bd1e-4a1c-b630-a89b27eb7ec4 61 fields · synced Jun 19, 2026
- EUDAMED 28209fcc-025c-4bf2-8d9f-f51d13bb12c7 61 fields · synced Jun 19, 2026