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Denrotary

by Ningbo Denrotary Medical Apparatus Co., Ltd. 4 variants

Ref BKEM180Model BKEM180、BKEM220、BKEM183、BKEM223、BKEM185、BKEM225、BKRM180、BKRM220、BKRM183、BKRM223、BKRM185、BKRM225、BKMM180、BKMM220、BKMM183、BKMM223、BKMM185、BKMM225、etc

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 Number697523815BKTENE Basic UDI-DI 06975238155003UDI-DIDate4 Mar 2025RegisteredStatusActive

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  • Withdrawn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 Brackets
Model / Reference
BKEM180、BKEM220、BKEM183、BKEM223、BKEM185、BKEM225、BKRM180、BKRM220、BKRM183、BKRM223、BKRM185、BKRM225、BKMM180、BKMM220、BKMM183、BKMM223、BKMM185、BKMM225、etc, BKEM180
Primary DI / UDI-DI
06975238155003
Basic UDI-DI
697523815BKTENE
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042109
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Ningbo Denrotary Medical Apparatus Co., Ltd.

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