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Surgical Lamp/Examination Lamp
EUDAMEDClass I (EU MDR)
Ref LP-BX01Model BXSL01、BXSL02、BXSL03、LP-BX01Ref BXSL02Ref BXSL01
Identity
- Device Name
- Surgical Lamp/Examination Lamp EUDAMED
- Model / Reference
- BXSL01、BXSL02、BXSL03、LP-BX01 EUDAMEDLP-BX01 EUDAMEDBXSL02 EUDAMEDBXSL01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971408226238 EUDAMED06971408226214 EUDAMED06971408226207 EUDAMED
- Basic UDI-DI
- 697140822SL01H8 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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: Endoscopic light source unit, line-powered
Surgical Lamp/Examination Lamp by Hebei Boxin Recovery Equipment CO., LTD — Class I — 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 | 697140822SL01H8 | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Boxin Recovery Equipment CO., LTD
- EUDAMED SRN
- CN-MF-000046611
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 73136751-cc94-4b06-bcff-5c5d364b2bd3 61 fields · synced Aug 2, 2026
- EUDAMED 0bd4deba-4640-421e-afb7-013dedc53f72 61 fields · synced May 18, 2026
- EUDAMED eb90e94b-a3ac-492f-bbe8-0a9048c991c1 61 fields · synced May 18, 2026