Brilliance
by Changzhou Sifary Medical Technology Co., Ltd. 4 variants
Part of a family of 29 devices: see the family page
Ref 5080479Model ibG3045D, ibG3045S
Brilliance (5080479) is a Class I device made by Changzhou Sifary Medical Technology Co., Ltd., registered in EUDAMED on 2 Feb 2026 (Basic UDI-DI 697259778IB002LH), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697259778IB002LH 06941877803261 | Date2 Feb 2026 | StatusActive |
Official records
- EUDAMED public site 697259778IB002LH
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- Withdrawn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 Binocular Loupes
- Model / reference
- ibG3045D, ibG3045S, 5080479
- Primary DI / UDI-DI
- 06941877803261
- Basic UDI-DI
- 697259778IB002LH
- EMDN code
- L0316 Helmets and binocular glasses for surgeons
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000010405
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Similar devices in this category
Other devices filed under HELMETS AND BINOCULAR GLASSES FOR SURGEONS.
Other devices from Changzhou Sifary Medical Technology Co., Ltd.
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