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Pulse Vacuum Sterilizer
EUDAMEDClass IIa (EU MDR)
Ref XG1.UModel XG1.U,MAST-A,MAST-H,MAST-C,MAST-V,Clean VSRef MAST-HRef MAST-V
Identity
- Trade Name
- Pulse Vacuum Sterilizer EUDAMED
- Device Name
- Pulse Vacuum Sterilizer EUDAMED
- Model / Reference
- XG1.U,MAST-A,MAST-H,MAST-C,MAST-V,Clean VS EUDAMEDXG1.U EUDAMEDMAST-H EUDAMEDMAST-V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614965054 EUDAMED06970614965023 EUDAMED06970614965030 EUDAMED
- Basic UDI-DI
- 697061496120002QY EUDAMED
- EMDN Code
- Z12011304 AUTOCLAVES WITH A CHAMBER LARGER THAN OR EQUAL TO 1 STANDARD STERILISATION UNIT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia EUDAMEDSlovenia 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
Pulse Vacuum 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 | 697061496120002QY | 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 (3)
- EUDAMED aec7fb11-88f3-4029-bb29-ffbf9d49bc19 61 fields · synced Jul 27, 2026
- EUDAMED 9a70f357-6efe-494e-ae6f-977fa69d9474 61 fields · synced May 17, 2026
- EUDAMED 1beba88c-46d2-4cc5-9a83-38cee08cffc0 61 fields · synced May 19, 2026