Brilliance

by Changzhou Sifary Medical Technology Co., Ltd. 4 variants

Part of a family of 29 devices: see the family page

Ref 5080618Model ibG3050D, ibG3050S

Brilliance (5080618) is a Class I device made by Changzhou Sifary Medical Technology Co., Ltd., registered in EUDAMED on 5 Feb 2026 (Basic UDI-DI 697259778IB003LK), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697259778IB003LK Basic UDI-DI 06941877808518UDI-DI	Date5 Feb 2026Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI 697259778IB003LK — open Devices and search for it

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name: Surgical Binocular Loupes
Model / reference: ibG3050D, ibG3050S, 5080618

Primary DI / UDI-DI: 06941877808518
Basic UDI-DI: 697259778IB003LK
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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Brilliance Elite

Class I

See all devices from Changzhou Sifary Medical Technology Co., Ltd. →

Properties

Other properties (14, all answered No)