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Cable I-Surge Led
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1601246-001Model Electric Micromtors
Identity
- Trade Name
- CABLE I-SURGE LED EUDAMEDFDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- Electric Micromtors EUDAMEDThe cables deliver electrical power only. Since they are not equipped with water connection, cables include a shield wire for motor grounding. FDA UDI
- Model / Reference
- Electric Micromtors EUDAMED1601246-001 EUDAMEDFDA UDI
- Description
- The cables deliver electrical power only. Since they are not equipped with water connection, cables include a shield wire for motor grounding. FDA UDI
Identifiers
- Primary DI / UDI-DI
- J00716012460011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007EMOT0001UH EUDAMED
- Direct Marketing DI
- J00716012460011 EUDAMED
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Dental power tool handpiece motorless component FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Cable I-Surge Led by Bien-Air Dental SA — 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 | ++J007EMOT0001UH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
- EUDAMED SRN
- CH-MF-000014661
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (2)
- EUDAMED 000ff217-3dee-4e94-9049-df94a7339ddd 61 fields · synced Oct 6, 2026
- FDA UDI d73971ce-d72c-4d46-b856-4bc350492c3b 34 fields · synced May 29, 2026