Curing Light
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Curing Light EUDAMEDREFINE FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Curing Light EUDAMED
- Model / Reference
- MaxCure9, MaxCure3, MaxCure5, MaxCure7, MaxCureG, MaxCureH, SWAN, A-Cure, A-Cure Plus, SWAN+ EUDAMEDMaxCureG EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971560454234 EUDAMEDFDA UDI
- Basic UDI-DI
- 697156045RCLS8 EUDAMED
- Direct Marketing DI
- 06971560454234 EUDAMED
- 510(k) Number
- K223414 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Dental/surgical polymerization lamp
Curing Light by Guilin Refine Medical Instrument 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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697156045RCLS8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guilin Refine Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012204
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED 05ac06c6-2e6a-4ba4-a2fd-bf7be0798e3b 61 fields · synced Jul 28, 2026
- FDA UDI 8c7beada-8517-4640-b484-b5b296813f78 33 fields · synced May 30, 2026