Identity
- Trade Name
- Steam Sterilizers EUDAMED
- Device Name
- Steam Sterilizers EUDAMED
- Model / Reference
- MAX-18L-III EUDAMEDyyyymmddxxx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975308820039 EUDAMED
- Basic UDI-DI
- 6975308822015211066936 EUDAMED
- Direct Marketing DI
- 06975308820039 EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
Yes
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: Sterilizer/disinfector rack
Steam Sterilizers by Ningbo Fenghua Runda Medical Apparatus 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 | 6975308822015211066936 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Fenghua Runda Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000025781
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 4b4dd0e6-c459-4fd5-800c-89acc6895e54 61 fields · synced Jul 8, 2026