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H2O2 Low Temperature Plasma Sterilizer
EUDAMEDClass IIa (EU MDR)
Ref GS-100XModel PS-40X,PS-100X,PS-100XP,PS-100GXP,PS-150X,GS-100X
Identity
- Trade Name
- H2O2 Low Temperature Plasma Sterilizer EUDAMED
- Device Name
- H2O2 Low Temperature Plasma Sterilizer EUDAMED
- Model / Reference
- PS-40X,PS-100X,PS-100XP,PS-100GXP,PS-150X,GS-100X EUDAMEDGS-100X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614968192 EUDAMED
- Basic UDI-DI
- 697061496120004R4 EUDAMED
- EMDN Code
- Z12011309 PLASMA STERILISERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
H2O2 Low Temperature Plasma Sterilizer by Shinva Medical Instrument Co., Ltd. — Class IIa — 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 | 697061496120004R4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shinva Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009856
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 710e0519-9f22-4ea3-b6b7-c8f175cacb0a 61 fields · synced Jun 18, 2026