Operating lamp
by Zhangjiagang Bestran Technology Co., Ltd 41 variants
Ref BT-LED200E, BT-LED5ID, BT-LED255, BT-LED3+4D, BT-LED01A, BT-LED260W, BT-LED700700F, BT-LED700500B, BT-LED5, BT-LED500FS, BT-LED4DW, BT-LED3D, BT-LED260C, BT-LED6+5A, BT-LED700500G, BT-LED5I, BT-LED500FE, BT-LED1SE, BT-LED500GS, BT-LED700500F, BT-LED500BW, BT-LED260, BT-LED4+4D, BT-LED5J, BT-LED700700B-TV, BT-LED11, BT-LED25, BT-LED700BW, BT-LED500HS, BT-LED4DS, BT-LED01F, BT-LED15E, BT-LED260E, BT-LED500500B, BT-LED6AS, BT-LED3+3D, BT-LED01W, BT-LED500BEModel 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
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697760627OL0001JD | Date10 Jul 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Operating lamp
- 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, BT-LED200E, BT-LED5ID, BT-LED3+4D, BT-LED01A, BT-LED260W, BT-LED700700F, BT-LED5, BT-LED500FS, BT-LED4DW, BT-LED3D, BT-LED260C, BT-LED6+5A, BT-LED700500G, BT-LED5I, BT-LED500FE, BT-LED1SE, BT-LED500GS, BT-LED700500F, BT-LED260, BT-LED4+4D, BT-LED5J, BT-LED11, BT-LED500HS, BT-LED4DS, BT-LED01F, BT-LED260E, BT-LED6AS, BT-LED3+3D, BT-LED01W
- Primary DI / UDI-DI
- 06977606274637, 06977606274439, 06977606274170, 06977606274460, 06977606274668, 06977606274569, 06977606274187, 06977606274019, 06977606274774, 06977606274224, 06977606274514, 06977606274507, 06977606274552, 06977606274248, 06977606274309, 06977606274422, 06977606274231, 06977606274712, 06977606274347, 06977606274194, 06977606274125, 06977606274576, 06977606274477, 06977606274446, 06977606274057, 06977606274729, 06977606274163, 06977606274118, 06977606274286, 06977606274521, 06977606274675, 06977606274149, 06977606274538, 06977606274026, 06977606274262, 06977606274484, 06977606274682, 06977606274101
- Basic UDI-DI
- 697760627OL0001JD
- EMDN Code
- Z12010702, Z12010701
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042782
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No