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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 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697259778IB002LH Basic UDI-DI 06941877803261UDI-DIDate2 Feb 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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.

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

Properties

Other properties (14, all answered No)