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Ear Syringe

by Albert Hohlkörper GmbH & Co. KG EUDAMED

Active European Union

Ref 8516.2.00000, 8514.2.00000, 8111.2.10535, 8506.2.10705

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40375663000M8 Basic UDI-DIDate4 Jan 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Ear Syringe
Model / Reference
8516.2.00000, 8514.2.00000, 8111.2.10535, 8506.2.10705
Primary DI / UDI-DI
04037566001383, 04037566001376, 04037566001642, 04037566001574
Basic UDI-DI
40375663000M8
EMDN Code
G020102,Q03040299, Q03040299
Device Class
Class I
Market of Registration
Italy
Germany
Denmark

Manufacturer details

EUDAMED SRN
DE-MF-000005482

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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