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Optical Frames

by Wenzhou Sunzone Industry & Trade Co., Ltd. 341 variants

Part of a family of 231 devices: see the family page

Ref BAF8031M-C3

Optical Frames (BAF8031M-C3) is a Class I device made by Wenzhou Sunzone Industry & Trade Co., Ltd., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 698042765ADJ), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698042765ADJ Basic UDI-DI 06980427653444UDI-DIDate20 Oct 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  • Withdrawn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

Model / reference
BAF8031M-C3
Primary DI / UDI-DI
06980427653444
Basic UDI-DI
698042765ADJ
EMDN code
Q02100203 Metal and plastic spectacle frames without lenses
Device class
Class I
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000028651
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Similar devices in this category

Other devices filed under CORRECTIVE OPTICAL DEVICES.

Other devices from Wenzhou Sunzone Industry & Trade Co., Ltd.

See all devices from Wenzhou Sunzone Industry & Trade Co., Ltd. →

Properties

Other properties (14, all answered No)