Identity
- Trade Name
- Cybird Gold EUDAMEDCybird FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Cybird EUDAMEDThis dental device is a curing unit intended for polymerization of light-cured materials by dental professionals. FDA UDI
- Model / Reference
- CGD EUDAMEDGOLD FDA UDI
- Description
- This dental device is a curing unit intended for polymerization of light-cured materials by dental professionals. FDA UDI
Identifiers
- Catalog Number
- GOLD FDA UDI
- Primary DI / UDI-DI
- 08800017900018 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000179CURINGLIGHT5E EUDAMED
- Direct Marketing DI
- 08800017900018 EUDAMED
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6070 FDA UDI
- Market of Registration
- Spain 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental appliance fabrication material, ceramic
Cybird Gold 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 | 88000179CURINGLIGHT5E | 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 42eba113-6bf5-4b4e-ae9b-c43cbaeb4da4 61 fields · synced Jul 26, 2026
- FDA UDI 71fa7768-a12b-43cb-99e5-170ce464a2db 36 fields · synced May 30, 2026