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Hu-Friedy
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref UI25KSF10RModel Ultrasonic Device
Identity
- Trade Name
- Hu-Friedy EUDAMEDFDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- After Five PLUS - Right, 25kHz FDA UDI
- Model / Reference
- Ultrasonic Device EUDAMEDUI25KSF10R EUDAMEDFDA UDI
- Description
- After Five PLUS - Right, 25kHz FDA UDI
Identifiers
- Catalog Number
- UI25KSF10R FDA UDI
- Primary DI / UDI-DI
- 10889950075316 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889950MagnetoExternalVT EUDAMED
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- Z12119006 DENTAL CLEANING/WASHING HANDPIECE EQUIPMENTS EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Hu-Friedy by Hu-Friedy Manufacturing Co., LLC — Class IIa — 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 | 0889950MagnetoExternalVT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hu-Friedy Manufacturing Co., LLC
- EUDAMED SRN
- US-MF-000017104
- Authorised Representative
- Hu-Friedy Europe LLC & Co. KG DE-AR-000005530
Sources (2)
- EUDAMED 87e706e6-5793-4eab-bcad-e06cf6dea020 61 fields · synced Jun 19, 2026
- FDA UDI 723d1d45-abfa-48cb-a9d7-7cdf59c5404d 35 fields · synced May 30, 2026