Surgical Light
by Bio Tech Health medical Supplies(Tianjin) Co., Ltd 39 variants
Ref BT-HL11Model BT-HL1 BT-HL2 BT-HL3 BT-HL4 BT-HL5 BT-HL6 BT-HL7 BT-HL8 BT-HL9 BT-HL10 BT-HL11 BT-HL12 BT-HL13 BT-HL14 BT-HL15 BT-HL16 BT-HL17 BT-HL18 BT-HL19 BT-HL20 BT-HL21 BT-HL22 BT-HL23 BT-HL24 BT-HL25 BT-HL26 BT-HL27 BT-HL28 BT-HL29 BT-HL30 BT-HL31 BT-HL32 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 | Number697788342BTKYL005RY 06977883422509 | Date27 Sep 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- Withdrawn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
- Surgical Light
- Model / Reference
- BT-HL1 BT-HL2 BT-HL3 BT-HL4 BT-HL5 BT-HL6 BT-HL7 BT-HL8 BT-HL9 BT-HL10 BT-HL11 BT-HL12 BT-HL13 BT-HL14 BT-HL15 BT-HL16 BT-HL17 BT-HL18 BT-HL19 BT-HL20 BT-HL21 BT-HL22 BT-HL23 BT-HL24 BT-HL25 BT-HL26 BT-HL27 BT-HL28 BT-HL29 BT-HL30 BT-HL31 BT-HL32 etc, BT-HL11
- Primary DI / UDI-DI
- 06977883422509
- Basic UDI-DI
- 697788342BTKYL005RY
- EMDN Code
- Z12010701 Fixed scialytic lamps
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044246
- 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