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Bl-401
EUDAMEDClass I (EU MDR)
Ref 3015531303Model BL-401，BL-402，BL-401A，BL-402A，BL-403，BL-404，BL-405，BL-406，BL-406A，BL-407，BL-408，BL-409
Identity
- Trade Name
- BL-401 EUDAMED
- Device Name
- Dental Curing Light EUDAMED
- Model / Reference
- BL-401，BL-402，BL-401A，BL-402A，BL-403，BL-404，BL-405，BL-406，BL-406A，BL-407，BL-408，BL-409 EUDAMED3015531303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975617284010 EUDAMED
- Basic UDI-DI
- 697561728LIGHTS5 EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bl-401 by Zhaoqing Gaoyao Recende Medical Equipment Co., LTD — Class I — 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 | 697561728LIGHTS5 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhaoqing Gaoyao Recende Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000028095
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3bd872fd-abf0-4c19-87e5-21ebe10f3fad 61 fields · synced Oct 6, 2026