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Ear Syringe

by Nanjing Ihome Comfort Co., Ltd 15 variants

Ref Ear Syringe 2ozModel 8/15/25/27/30/33/35/41/55/60/65/70/75/90/120/125/135/175/200/206/205/250/317/330/490/700ml、1/2/3oz

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, self-declared

Class I: no certifier involved

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 Number697591877ES11SW Basic UDI-DI 06975918771158UDI-DIDate25 Dec 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Ear Syringe
Model / Reference
8/15/25/27/30/33/35/41/55/60/65/70/75/90/120/125/135/175/200/206/205/250/317/330/490/700ml、1/2/3oz, Ear Syringe 2oz
Primary DI / UDI-DI
06975918771158
Basic UDI-DI
697591877ES11SW
EMDN Code
Z12149085 Various ENT instruments - consumables
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000037214
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Nanjing Ihome Comfort Co., Ltd

See all devices from Nanjing Ihome Comfort 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