Identity
- Trade Name
- Autoclave EUDAMEDSHINVA FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- Autoclave EUDAMED
- Model / Reference
- MOST-T EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970614965115 EUDAMED06970614967416 FDA UDI
- Basic UDI-DI
- 697061496120001QW EUDAMED
- 510(k) Number
- K220102 FDA UDI
- FDA Product Code
- FLE FDA UDI
- EMDN Code
- Z12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6880 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Autoclave by Shinva Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220102 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697061496120001QW | 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 b41c836c-5485-49cb-a8f1-0e1cf4febef1 61 fields · synced Jul 17, 2026
- FDA UDI 2c90a3b0-da7d-4856-aa5a-405da58ea1e8 33 fields · synced May 29, 2026
- FDA 510(k) K220102 1 fields · synced May 18, 2026