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ACE Ovum Pickup Needle

by Allwin Medical Devices, Inc United States EUDAMED

Ref A-OVM-SL18/35Model ACE Single Lumen Ovum Pickup Needle,ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line,ACE-M Manual Single Lumen Ovum Pickup Needle,OVUMPICK Double Lumen Ovum Pickup Needle,EAGLE Single Lumen Ovum Pickup Needle EMDN Z12080202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081226101OPN058UV Basic UDI-DIDate2 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Ovum Pickup Needle
Model / Reference
ACE Single Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, EAGLE Single Lumen Ovum Pickup Needle, A-OVM-SL18/35
Primary DI / UDI-DI
00819374022545
Basic UDI-DI
081226101OPN058UV
EMDN Code
Z12080202 Oocyte aspiration equipment
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
US-MF-000011349
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Allwin Medical Devices, Inc.

See all devices from Allwin Medical Devices, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED cad7cdbf-1259-4f00-91d8-aa950ecb06b0 61 fields · synced 24 Oct 2026