Low Temperature Hydrogen Peroxide Sterilizer
by RENOSEM Co., Ltd. South Korea EUDAMED
Ref REOM-004Model RENO-S130 EMDN S900199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberKR25/00000036 | Date23 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- KR25/00000036 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 23 Sep 2025
- Expires
- 7 Mar 2030
- Reason
- Add device or group
Specification
- Device Name
- Low Temperature Hydrogen Peroxide Sterilizer
- Model / Reference
- RENO-S130, REOM-004
- Primary DI / UDI-DI
- 08809293780178
- Basic UDI-DI
- 880929378017MP
- Direct Marketing DI
- 08809293780178
- EMDN Code
- S900199 Devices for gas plasma sterilisation (excluding cat. d - z) - other
- Device Class
- Class IIa
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- KR-MF-000023080
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from RENOSEM Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 8885d6e9-353b-49fa-8575-a69b74129e85