Operating lamp
by Zhangjiagang Bestran Technology Co., Ltd 41 variants
Ref BT-LED3FModel 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
CE MDR
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 06977606274385 | 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- Withdrawn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-LED3F
- Primary DI / UDI-DI
- 06977606274385
- Basic UDI-DI
- 697760627OL0001JD
- EMDN Code
- Z12010701 Fixed scialytic lamps
- 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
Other devices from Zhangjiagang Bestran Technology Co., Ltd
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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