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Ear Wax Removal Kit

by Ningbo Albert Novosino Co., Ltd.

Ref 300mlModel 10ml, 20ml, 30ml, 50ml, 60ml, 70ml, 80ml, 90ml, 100ml, 120ml, 125ml, 150ml, 200ml, 240ml, 250ml, 300ml, 350ml, 400ml, 450ml, 500ml, 600ml, 700ml, 800ml, 900ml, 1000ml

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971919467328 UDI-DI Date28 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697191946ERKV5 Basic UDI-DI 06971919467328UDI-DIDate20 Apr 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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ear Wax Removal Kit EUDAMED
TopQuaFocus GUDID
Generic Name
Ear canal irrigation kit, reusable
Device Name
Earwax Removal Kit
Model / Reference
10ml, 20ml, 30ml, 50ml, 60ml, 70ml, 80ml, 90ml, 100ml, 120ml, 125ml, 150ml, 200ml, 240ml, 250ml, 300ml, 350ml, 400ml, 450ml, 500ml, 600ml, 700ml, 800ml, 900ml, 1000ml
Primary DI / UDI-DI
06971919467328
Basic UDI-DI
697191946ERKV5
FDA Product Code
OGQ
EMDN Code
Q03040299 Ear irrigation devices - other
GMDN Term
Ear canal irrigation kit, reusable
Device Class
Class I
Regulation Number
880.6960
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000008571
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Ningbo Albert Novosino Co., Ltd.

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Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No