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LED dental light
EUDAMEDClass I (EU MDR)
Ref 06971608314513Model Orion, Hubble, Hubble II, Amber, Amber II, Pebble, Pebble II, Leo, Libra
Identity
- Trade Name
- LED dental light EUDAMED
- Device Name
- LED dental light EUDAMED
- Model / Reference
- Orion, Hubble, Hubble II, Amber, Amber II, Pebble, Pebble II, Leo, Libra EUDAMED06971608314513 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971608314513 EUDAMED
- Basic UDI-DI
- 697160831LEDDentalLightGC EUDAMED
- Direct Marketing DI
- 06971608314513 EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
LED dental light by Guangzhou Ajax Medical Equipment Co., Ltd. — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697160831LEDDentalLightGC | Class I | Active |
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Manufacturer
- Manufacturer
- Guangzhou Ajax Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000016044
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 131c31d0-82f8-4589-927b-847d4d0f406b 61 fields · synced Oct 6, 2026