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Hose Isolite/Mc2 Swivel Grey
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1600298-001Model Electric Micromtors
Identity
- Trade Name
- HOSE ISOLITE/MC2 SWIVEL GREY EUDAMEDFDA UDI
- Generic Name
- Pneumatic dental power tool hose FDA UDI
- Device Name
- Electric Micromtors EUDAMEDHoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device. FDA UDI
- Model / Reference
- Electric Micromtors EUDAMED1600298-001 EUDAMEDFDA UDI
- Description
- Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device. FDA UDI
Identifiers
- Catalog Number
- 1600298-001 FDA UDI
- Primary DI / UDI-DI
- J00716002980011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007EMOT0001UH EUDAMED
- Direct Marketing DI
- J00716002980011 EUDAMED
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Pneumatic dental power tool hose FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria 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
Hose Isolite/Mc2 Swivel Grey 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 49f949bf-6a58-48cc-a3c5-2b0a69c73d68 61 fields · synced Jul 28, 2026
- FDA UDI f36981d6-22b6-4eb5-bde6-4df07e55ed5f 35 fields · synced May 30, 2026