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Cal8l
EUDAMEDClass IIa (EU MDR)
Ref 668Model SEA23L, SEA18L，STE16L, STE12L, STE8L, CAL23L，CAL18L,CAL16L，CAL12L, CAL8L
Identity
- Trade Name
- CAL8L EUDAMED
- Device Name
- Small Steam Sterilizers EUDAMED
- Model / Reference
- SEA23L, SEA18L，STE16L, STE12L, STE8L, CAL23L，CAL18L,CAL16L，CAL12L, CAL8L EUDAMED668 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721256685 EUDAMED
- Basic UDI-DI
- 697472125SEA003FV 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
- Germany 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
Cal8l 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 1c20aba0-dfc2-4480-91ed-15d63af2a1f7 61 fields · synced Jul 21, 2026