Medical Headlight
by Xenosys Co., Ltd. 6 variants
Ref L2SX5
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 | Number88001577L2S00007V 08800157700172 | Date24 Aug 2026 | 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- Withdrawn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
- Medical Headlight
- Model / Reference
- L2SX5
- Primary DI / UDI-DI
- 08800157700172
- Basic UDI-DI
- 88001577L2S00007V
- EMDN Code
- Z12010799 Scialytic lamp lighting systems - other
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- KR-MF-000054663
- Authorised representative
- S.B. Pharma GmbH DE-AR-000005392
Other devices from Xenosys Co., Ltd.
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