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SET Chiropro 3rd Gen CA 20:1 L KM
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1700736-001Model CHIROPRO
Identity
- Trade Name
- SET Chiropro 3rd Gen CA 20:1 L KM EUDAMEDSET CHIROPRO 3rd Gen KM FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- CHIROPRO EUDAMEDSets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories FDA UDI
- Model / Reference
- CHIROPRO EUDAMED1700736-001 EUDAMEDFDA UDI
- Description
- Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories FDA UDI
Identifiers
- Catalog Number
- 1700736-001 FDA UDI
- Primary DI / UDI-DI
- J00717007360011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007CHIR0001MJ EUDAMED
- Direct Marketing DI
- J00717007360011 EUDAMED
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered 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
Yes
FDA UDI
SET Chiropro 3rd Gen CA 20:1 L KM 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 | ++J007CHIR0001MJ | 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 35ce1390-5f2d-430d-8214-35342aa7b360 61 fields · synced Jun 18, 2026
- FDA UDI 6f9d612a-eb36-4e78-aafa-2b23fdc1a706 35 fields · synced May 30, 2026