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Maple 42U
EUDAMEDClass IIa (EU MDR)
Ref 06974721255008V08020199Model Maple 42D, Maple 42U
Identity
- Trade Name
- Maple 42U EUDAMED
- Device Name
- Integral Dental Unit Chair EUDAMED
- Model / Reference
- Maple 42D, Maple 42U EUDAMED06974721255008V08020199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974721255008 EUDAMED
- Basic UDI-DI
- 697472125MAPLE42001Y4 EUDAMED
- Direct Marketing DI
- 06974721255008 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS 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
Category: Dental delivery system
Maple 42U by Ningbo Runyes Medical Instrument 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 | 697472125MAPLE42001Y4 | 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 8a50e94e-0523-4a69-a55f-5699ca45864d 61 fields · synced Jun 17, 2026