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Bracket

by Zhejiang Shinye Medical Technology Corp., Ltd. 979 variants

Ref 8315-21E-34-10Model Mini Transcend MIM Brackets (MBT*)

Bracket (8315-21E-34-10) is a Class IIa device made by Zhejiang Shinye Medical Technology Corp., Ltd., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-06942054795171), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06942054795171 Basic UDI-DI 06942054795171UDI-DIDate6 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
Mini Transcend MIM Brackets (MBT*), 8315-21E-34-10
Primary DI / UDI-DI
06942054795171
Basic UDI-DI
B-06942054795171
EMDN code
Q010403 Orthodontic brackets and buttons
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023934
Authorised representative
Lotus NL B.V. NL-AR-000000121

Similar devices in this category

Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.

Other devices from Zhejiang Shinye Medical Technology Corp., Ltd.

See all devices from Zhejiang Shinye Medical Technology Corp., Ltd. →

Properties

  • Sterilise before use
Other properties (11, all answered No)