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Endoscope Light Source
EUDAMEDClass IIa (EU MDR)
Ref HB300R-TModel HB300RRef HB100Model HB500Ref HB300-TECRef HB300R-SRef HB100-TEC
Identity
- Device Name
- Endoscope Light Source EUDAMED
- Model / Reference
- HB300R EUDAMEDHB300R-T EUDAMEDHB500 EUDAMEDHB100 EUDAMEDHB300-TEC EUDAMEDHB300R-S EUDAMEDHB100-TEC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936415979508 EUDAMED06936415979478 EUDAMED06903053047104 EUDAMED06903053047098 EUDAMED06936415979492 EUDAMED06903053047111 EUDAMED
- Basic UDI-DI
- 69449040AB0651000385 EUDAMED69449040AB065100098H EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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: Endoscopic light source unit, line-powered
Endoscope Light Source by Shenzhen Mindray Bio-Medical Electronics Co., LTD — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light source unit, line-powered.
- Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
- SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
- SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
- LED 610 Light source — Erbe Vision GmbH · Class I
- SPOTLIGHT — Depuy Spine, Inc. · Class II
- SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
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 | 69449040AB0651000385 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED b4050f24-63c0-482e-b852-690a3f585767 61 fields · synced Aug 4, 2026
- EUDAMED 626c1d7a-c6bb-4fde-8604-5e0fc6fa5135 61 fields · synced May 17, 2026
- EUDAMED 83b4d9cf-7f7b-434f-ac42-e307da1bd1de 61 fields · synced May 18, 2026
- EUDAMED bf3cb4e9-0e9b-4da3-bb8f-60f06632f598 61 fields · synced May 18, 2026
- EUDAMED 8fbad3d5-0fc2-42c0-833c-0c321642a750 61 fields · synced May 19, 2026
- EUDAMED 17a249ba-2f38-423b-9b01-b8e71a5fe394 61 fields · synced May 19, 2026