Identity
- Trade Name
- Sanacide EUDAMEDSanacide-R7 EUDAMED
- Device Name
- Peracetic acid based Disinfectant for Hemodialysis Machine EUDAMED
- Model / Reference
- EP001 EUDAMEDR7001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580153781361 EUDAMED04580153781378 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
Sanacide 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 (2)
- EUDAMED 8e4606d9-845e-4e1b-b7ff-3923925579d5 61 fields · synced Jul 25, 2026
- EUDAMED 2f8b67e6-291e-44a3-ac83-5ff727907cd3 61 fields · synced May 17, 2026