Identity
- Trade Name
- COXO FDA UDI
- Generic Name
- Dental amalgam mixer FDA UDI
- Device Name
- Amalgamators EUDAMEDFDA UDI
- Model / Reference
- DB338 EUDAMEDFDA UDI
- Description
- Amalgamators FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974267890688 EUDAMEDFDA UDI
- Basic UDI-DI
- 697426789068Q8 EUDAMED
- FDA Product Code
- EFD FDA UDI
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
- GMDN Term
- Dental amalgam mixer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3100 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
Yes
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
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
Yes
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
Amalgamators by Foshan COXO Medical Instrument Co., Ltd. — Class I — 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 | 697426789068Q8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 972c9153-9cf9-4ead-93fb-ca4e00e19c79 61 fields · synced Oct 6, 2026
- FDA UDI 38ff16b9-b6b0-48fe-804d-1e0258303b85 33 fields · synced May 30, 2026