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Operating lamp
EUDAMEDClass I (EU MDR)
Ref BT-LED1SCModel BT-LED700700B,BT-LED700500B,BT-LED500500B,BT-LED700B,BT-LED500B,BT-LED700700B-TV,BT-LED700500B-TV,BT-LED700BS,BT-LED700BE,BT-LED500BS,BT-LED500BE,BT-LED700BW,BT-LED500BW,BT-LED15S,BT-LED15E,BT-LED25W,BT-LED25,BT-LED255,etc
Identity
- Device Name
- Operating lamp EUDAMED
- Model / Reference
- BT-LED700700B,BT-LED700500B,BT-LED500500B,BT-LED700B,BT-LED500B,BT-LED700700B-TV,BT-LED700500B-TV,BT-LED700BS,BT-LED700BE,BT-LED500BS,BT-LED500BE,BT-LED700BW,BT-LED500BW,BT-LED15S,BT-LED15E,BT-LED25W,BT-LED25,BT-LED255,etc EUDAMEDBT-LED1SC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977606274705 EUDAMED
- Basic UDI-DI
- 697760627OL0001JD EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS 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
Operating lamp by Zhangjiagang Bestran Technology 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 | 697760627OL0001JD | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangjiagang Bestran Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000042782
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 61eff990-3034-41d8-855f-69c67d6074fb 61 fields · synced Jun 19, 2026