Identity
- Trade Name
- Amzyme 3 Manual EUDAMED
- Device Name
- VZF EUDAMED
- Model / Reference
- J48CM EUDAMEDJ48BM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060722251628 EUDAMED05060722251604 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 EUDAMEDBelgium 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
Amzyme 3 Manual 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 (4)
- EUDAMED 308208fc-9c98-4330-9260-232f34560f59 61 fields · synced Jul 13, 2026
- EUDAMED 35c8d117-653f-4bb7-9aba-900048d789fc 61 fields · synced May 17, 2026
- EUDAMED 550cc3bf-d2b8-4239-a7a0-c216378e1928 61 fields · synced Jun 18, 2026
- EUDAMED ecc7f580-6e02-4cc1-89b7-57ee5ed63fee 61 fields · synced Jul 13, 2026