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Curing Light
EUDAMEDClass I (EU MDR)
Ref MaxCure7Model MaxCure9, MaxCure3, MaxCure5, MaxCure7, MaxCureG, MaxCureH, SWAN, A-Cure, A-Cure Plus, SWAN+
Identity
- Trade Name
- Curing Light EUDAMED
- Device Name
- Curing Light EUDAMED
- Model / Reference
- MaxCure9, MaxCure3, MaxCure5, MaxCure7, MaxCureG, MaxCureH, SWAN, A-Cure, A-Cure Plus, SWAN+ EUDAMEDMaxCure7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971560453749 EUDAMED
- Basic UDI-DI
- 697156045RCLS8 EUDAMED
- Direct Marketing DI
- 06971560453749 EUDAMED
- EMDN Code
- Z12119003 COLD LIGHT DENTAL EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental/surgical polymerization lamp
Curing Light by Guilin Refine Medical Instrument Co., Ltd. — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697156045RCLS8 | Class I | Active |
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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 (1)
- EUDAMED e641e9b1-aef5-4deb-a91d-e9c377d9d4eb 61 fields · synced Oct 6, 2026