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Dental Chair
EUDAMEDClass I (EU MDR)
Ref X008Model PM-2311, PM-231118, PM-2318L5, PM-3280, PM-3260, PM-3290, PM-3250, PM-3270, X008, X009, X142, X144, X146, X147, X148, X149
Identity
- Trade Name
- Dental Chair EUDAMED
- Device Name
- Dental Chair EUDAMED
- Model / Reference
- PM-2311, PM-231118, PM-2318L5, PM-3280, PM-3260, PM-3290, PM-3250, PM-3270, X008, X009, X142, X144, X146, X147, X148, X149 EUDAMEDX008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226452088 EUDAMED
- Basic UDI-DI
- 697722645BTDC01LV EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Dental Chair by Nanjing Poweam Medical Co., Ltd — Class I — 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 | 697722645BTDC01LV | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Poweam Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000040207
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f92cebb0-31ef-4023-82a5-b784ac2b7ca3 61 fields · synced Jun 19, 2026