Identity
- Trade Name
- NClean-PAA EUDAMED
- Device Name
- Peracetic acid based Disinfectant for Hemodialysis Machine EUDAMED
- Model / Reference
- PAA_001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580153781477 EUDAMED
- Basic UDI-DI
- 458015378SanacideSeries57 EUDAMED
- EMDN Code
- D050101 PERACETIC AND ACETIC ACID WITH HYDROGEN PEROXIDE FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb 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
NClean-PAA by Amtec Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 458015378SanacideSeries57 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Amtec Co., Ltd.
- EUDAMED SRN
- JP-MF-000001277
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c7071bb0-f8a3-4d5d-93ab-b51758c44aad 61 fields · synced Jul 20, 2026