Identity
- Trade Name
- Amity PAA 5 System - Part A EUDAMED
- Device Name
- Amity PAA 5 System - Part A EUDAMED
- Model / Reference
- J82C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060722250447 EUDAMED
- Basic UDI-DI
- B-05060722250447 EUDAMED
- EMDN Code
- D050101 PERACETIC AND ACETIC ACID WITH HYDROGEN PEROXIDE FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Amity PAA 5 System - Part A by Amity Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060722250447 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Amity Limited
- EUDAMED SRN
- GB-MF-000023321
- Authorised Representative
- Amity Healthcare EU Ltd. IE-AR-000011613
Sources (1)
- EUDAMED 4e169403-14b4-4da9-a729-3d2e6d5fb32c 61 fields · synced Jun 19, 2026