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Dental Operating Light
EUDAMEDFDA UDIClass I (EU MDR)
Ref NicedayModel LEDlight Plus
Identity
- Trade Name
- Dental Operating Light EUDAMEDPurevac HVE System FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- Dental Operating Light EUDAMEDHVE Mirror Tips and Hose Adapter Starter Kit FDA UDI
- Model / Reference
- LEDlight Plus EUDAMEDNiceday EUDAMEDHVE Mirror Tips and Hose Adapter Starter Kit FDA UDI
- Description
- HVE Mirror Tips and Hose Adapter Starter Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971951789983 EUDAMEDFDA UDI
- Basic UDI-DI
- 697195178999QF EUDAMED
- Direct Marketing DI
- 06971951789983 EUDAMED
- FDA Product Code
- EAX FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Dental mirror, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dental Operating Light by Medfruition Electronics Technology Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697195178999QF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medfruition Electronics Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000019634
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 10951315-7f91-48b4-b681-77a4be0a1594 61 fields · synced Jul 9, 2026
- FDA UDI 921b6bae-add5-450e-b15c-deb7db308a89 33 fields · synced May 30, 2026