Ecoplasma
by Sterifast - Sterilization & Disinfection Systems Lda. Portugal EUDAMED
Ref STFE1101SD-B, STFE0502SD-B, STFE1102SD-B, STFE0501SD-BModel ECOPLASMA E110 1SD-B, ECOPLASMA E50 2SD-B, ECOPLASMA E110 2SD-B , ECOPLASMA E50 1SD-B
EMDN Z12011309
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05600778703063 | Date6 Oct 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Hydrogen Peroxide Low Temperature Sterilizer with Low Concentration
- Model / Reference
- ECOPLASMA E110 1SD-B, STFE1101SD-B, ECOPLASMA E50 2SD-B, STFE0502SD-B, ECOPLASMA E110 2SD-B, STFE1102SD-B, ECOPLASMA E50 1SD-B, STFE0501SD-B
- Primary DI / UDI-DI
- 05600778703063, 05600778703032, 05600778703070, 05600778703025
- Basic UDI-DI
- B-05600778703063, B-05600778703032, B-05600778703070, B-05600778703025
- EMDN Code
- Z12011309, S900199
- Device Class
- Class IIb
- Market of Registration
- PolandPortugal
Manufacturer details
- EUDAMED SRN
- PT-MF-000012426
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (4)
- EUDAMED f913d93e-8af4-4a4c-a7f2-b3dbb800069c
- EUDAMED 05600778703032|B-05600778703032
- EUDAMED 05600778703070|B-05600778703070
- EUDAMED 05600778703025|B-05600778703025