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Operating lamp
EUDAMEDClass I (EU MDR)
Ref BT-LED3FSModel 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-LED3FS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977606274408 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 829db520-00cf-4346-a990-1218f453ed03 61 fields · synced Jun 19, 2026