Identity
- Trade Name
- NClean-CA30 EUDAMED
- Device Name
- Organic acid based Disinfectant for Hemodialysis Machine EUDAMED
- Model / Reference
- CA30_001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580153781491 EUDAMED
- Basic UDI-DI
- 458015378CitrixSeriesJG EUDAMED
- EMDN Code
- D99 DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER 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-CA30 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 | 458015378CitrixSeriesJG | 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 ef868222-c66e-4604-812d-bbbfa7032bd9 61 fields · synced Jun 18, 2026