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Dental Operating Light
EUDAMEDFDA UDIClass I (EU MDR)
Ref LED-5Model LEDlight Plus
Identity
- Trade Name
- Dental Operating Light EUDAMEDFDA UDI
- Generic Name
- LED dental light, line-powered FDA UDI
- Device Name
- Dental Operating Light EUDAMED
- Model / Reference
- LEDlight Plus EUDAMEDLED-5 EUDAMEDNiceday FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971951789976 EUDAMEDFDA UDI
- Basic UDI-DI
- 697195178999QF EUDAMED
- Direct Marketing DI
- 06971951789976 EUDAMED
- FDA Product Code
- EAZ FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- LED dental light, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4630 FDA UDI
- Market of Registration
- Slovakia 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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 54b4512a-74a3-4e96-b4a0-73d4add81430 61 fields · synced May 30, 2026
- FDA UDI 84da0298-ca28-4782-bfe7-b67061e5efc8 32 fields · synced May 30, 2026