Identity
- Trade Name
- COXO FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- Straight Handpieces EUDAMEDFDA UDI
- Model / Reference
- CX235-2 EUDAMEDFDA UDIS-2 EUDAMED
- Description
- Straight Handpieces FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974267890268 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06974267890268 EUDAMED
- 510(k) Number
- K220179 FDA UDI
- FDA Product Code
- EFB FDA UDIEGS FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Straight Handpieces by Foshan COXO Medical Instrument Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974267890268 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Foshan COXO Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001682
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 3797470c-7193-4467-b0d1-802411dd53d2 61 fields · synced Jun 15, 2026
- FDA UDI 68311166-fe4d-4bbb-97bd-e07b253ef63d 34 fields · synced May 30, 2026