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Sea18l
EUDAMEDClass IIa (EU MDR)
Ref 06974721256036Model SEA23L, SEA18L，STE16L, STE12L, STE8L, CAL23L，CAL18L,CAL16L，CAL12L, CAL8L
Identity
- Trade Name
- SEA18L EUDAMED
- Device Name
- Small Steam Sterilizers EUDAMED
- Model / Reference
- SEA23L, SEA18L，STE16L, STE12L, STE8L, CAL23L，CAL18L,CAL16L，CAL12L, CAL8L EUDAMED06974721256036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721256036 EUDAMED
- Basic UDI-DI
- 697472125SEA003FV EUDAMED
- Direct Marketing DI
- 06974721256036 EUDAMED
- EMDN Code
- Z12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Sea18l by Ningbo Runyes 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 | 697472125SEA003FV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Runyes Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000014741
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6e612cce-7f03-447e-9058-1a09f8d4e13c 61 fields · synced Jun 18, 2026