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H2O2 Low Temperature Plasma Sterilizer
EUDAMEDClass IIa (EU MDR)
Ref PS-100GXPModel PS-40X,PS-100X,PS-100XP,PS-100GXP,PS-150X,GS-100XRef PS-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 EUDAMEDPS-100GXP EUDAMEDPS-100X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614964989 EUDAMED06970614964965 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
Category: Plasma sterilizer
H2O2 Low Temperature Plasma Sterilizer by Shinva Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (2)
- EUDAMED 3a07e63c-df31-46c9-a332-8942be82514b 61 fields · synced Jul 20, 2026
- EUDAMED cee190e8-5b55-4139-9222-7f01be0ea789 61 fields · synced May 17, 2026