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orthodontic bracket

by Zhejiang Risheng Medical Technology Co., Ltd 922 variants

Ref 121, BSR2-1123, SQM2-3407, SMM2-3407a, SMD2-3407, CMM2-0401, BQR2-0301, BQK1-2401, SMQ2-3301, SMQ2-3307, BSM1-0401d, BQM2-2033, BSR1-2301, BSM1-2401, BQM2-2034, SMH2-3407, BSR2-1114, SMQ2-330K, BSR2-1113, BQM2-2013, SML2-3407, BSM1-0301, BQR1-0401, SMM1-3407, BQM1-0301, BQM2-2014h, BSR1-0301, BQM2-2015a, SMQ2-3406, BQM2-2011, BQM2-0301, STR2-2401, SQH2-3302, SMQ2-3304, BSR2-1012, BQR1-2401, BSR2-1011, BSR2-1022, BSM2-2301, BQR1-0301, SMQ2-330Q, SOH2-3407, SQM2-3301, BSR2-1115, BQM2-2014a, SMQ2-3407, BQM2-2035a, SOM2-3007, BQM2-2023, BSR1-2401, SOL2-3407Model ligating bracket MBT 0.018", Ligating

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697146493BM1RC Basic UDI-DIDate6 Jun 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
orthodontic bracket
Model / Reference
ligating bracket MBT 0.018", 121, Ligating, BSR2-1123, SQM2-3407, SMM2-3407a, SMD2-3407, CMM2-0401, BQR2-0301, BQK1-2401, SMQ2-3301, SMQ2-3307, BSM1-0401d, BQM2-2033, BSR1-2301, BSM1-2401, BQM2-2034, SMH2-3407, BSR2-1114, SMQ2-330K, BSR2-1113, BQM2-2013, SML2-3407, BSM1-0301, BQR1-0401, SMM1-3407, BQM1-0301, BQM2-2014h, BSR1-0301, BQM2-2015a, SMQ2-3406, BQM2-2011, BQM2-0301, STR2-2401, SQH2-3302, SMQ2-3304, BSR2-1012, BQR1-2401, BSR2-1011, BSR2-1022, BSM2-2301, BQR1-0301, SMQ2-330Q, SOH2-3407, SQM2-3301, BSR2-1115, BQM2-2014a, SMQ2-3407, BQM2-2035a, SOM2-3007, BQM2-2023, BSR1-2401, SOL2-3407
Primary DI / UDI-DI
06971464935594, 06936463833975, 06977566458375, 06977566457767, 06936463800007, 06936463834002, 06971464937666, 06971464934467, 06977566458160, 06977566458191, 06977566451802, 06971464935877, 06977566454742, 06977566452410, 06971464935884, 06977566456289, 06936463833937, 06977566458207, 06936463833920, 06971464935723, 06977566456715, 06977566451789, 06971464936805, 06977566457187, 06971464934672, 06971464935754, 06977566454087, 06971464935778, 06977566458252, 06971464935709, 06971464935600, 06977566459082, 06977566458320, 06977566458184, 06936463833913, 06971464937314, 06936463833906, 06936463833968, 06977566453653, 06971464936799, 06977566458214, 06977566458276, 06977566458368, 06936463833944, 06971464935747, 06977566458269, 06971464935914, 06977566458290, 06971464935808, 06977566454759, 06977566458283
Basic UDI-DI
697146493BM1RC, 697146493BL2K
Direct Marketing DI
06971464935594
06936463833975
06977566458375
06977566457767
06936463800007
06936463834002
06971464937666
06971464934467
06977566458160
06977566458191
06977566451802
06971464935877
06977566454742
06977566452410
06971464935884
06977566456289
06936463833937
06977566458207
06936463833920
06971464935723
06977566456715
06977566451789
06971464936805
06977566457187
06971464934672
06971464935754
06977566454087
06971464935778
06977566458252
06971464935709
06971464935600
06977566459082
06977566458320
06977566458184
06936463833913
06971464937314
06936463833906
06936463833968
06977566453653
06971464936799
06977566458214
06977566458276
06977566458368
06936463833944
06971464935747
06977566458269
06971464935914
06977566458290
06971464935808
06977566454759
06977566458283
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000011127
Authorised representative
Lotus NL B.V. NL-AR-000000121

Related devices

Category: Orthodontic tube

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No