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Hearing Aid

by Tmore Medical （Shenzhen）Co. Ltd 22 variants

Ref 3308Model 5118DL/5118L/5120L/5122L/5124L/5126L/5128L/5130L/5112L/5116L/5216L/3308/1118/1120/1122 /1124/1216/6118/6120/6121/6122/6126/6128

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697611083HR001CF Basic UDI-DI 06976110832845UDI-DIDate13 Jul 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
5118DL/5118L/5120L/5122L/5124L/5126L/5128L/5130L/5112L/5116L/5216L/3308/1118/1120/1122 /1124/1216/6118/6120/6121/6122/6126/6128, 3308
Primary DI / UDI-DI
06976110832845
Basic UDI-DI
697611083HR001CF
EMDN Code
Y2145060101 Behind-the-ear hearing aids with receiver in the device (bte)
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000056293
Authorised representative
Humiss Beratung GmbH DE-AR-000023447

Other devices from Tmore Medical （Shenzhen）Co. Ltd

See all devices from Tmore Medical （Shenzhen）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