Brilliance Elite
by Changzhou Sifary Medical Technology Co., Ltd. United States EUDAMED
Ref 5088164Model ibT5035E, ibT5040E, ibT5045E, ibT5050E
EMDN L0316
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697259778IB016LU | Date29 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Surgical Binocular Loupes
- Model / Reference
- ibT5035E, ibT5040E, ibT5045E, ibT5050E, 5088164
- Primary DI / UDI-DI
- 06941877828905
- Basic UDI-DI
- 697259778IB016LU
- EMDN Code
- L0316 Helmets and binocular glasses for surgeons
- Device Class
- Class I
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000010405
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Changzhou Sifary Medical Technology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 06941877828905|697259778IB016LU