Identity
- Trade Name
- Triozyme EUDAMED
- Device Name
- VZF EUDAMED
- Model / Reference
- 40003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060722253080 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 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
Triozyme by Amity Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Medical device disinfection agent.
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class I
- Instru Zym — Laboratorium Dr. Deppe GmbH · Class I
- Your First Enzymatic & Non-Enzymatic Sponges — BATRIK MEDICAL MANUFACTURING INC. · Class I
- Rapidzyme PR — Novapharm Research (Australia) Pty Ltd · Class IIb
- Coltene Biosonic UC40 — Topdental (Products) Ltd · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · Class I
- Sterilbios — AMIL CARE CORPORATION · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amity Limited
- EUDAMED SRN
- GB-MF-000023321
- Authorised Representative
- Amity Healthcare EU Ltd. IE-AR-000011613
Sources (2)
- EUDAMED b2de0d25-dcde-4778-9473-3fa053c3ecad 61 fields · synced Jun 18, 2026
- EUDAMED 2d78d0bc-42fa-42c0-a766-a55214f8a100 61 fields · synced Jun 18, 2026