Identity
- Trade Name
- DX-Mixer 110 EUDAMEDDX-Mixer FDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- Dental Impression Material Mixing tip EUDAMEDThe dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impression. The dental impression material is normally housed in cartridge assembly. The impression cartridge assembly consists of a base impression cartridge and a catalyst impression cartridge parts each. FDA UDI
- Model / Reference
- DX-Mixer110 EUDAMED110 FDA UDI
- Description
- The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impression. The dental impression material is normally housed in cartridge assembly. The impression cartridge assembly consists of a base impression cartridge and a catalyst impression cartridge parts each. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017901657 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000179DXMIXERUG EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material mixing nozzle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, ceramic
DX-Mixer 110 by Dxm Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 88000179DXMIXERUG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DXM Co., Ltd.
- EUDAMED SRN
- KR-MF-000016586
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 54d9ec24-a003-4afb-bb37-31e7f43b9020 61 fields · synced Jul 10, 2026
- FDA UDI f6a47348-e931-4066-a5ec-b47673dda958 33 fields · synced May 30, 2026