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FALCON Single Lumen Ovum Pickup Needle

by Allwin Medical Devices, Inc

Ref F-OVM-SL17/35Model 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

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081226101OPN058UV Basic UDI-DI 00819374025607UDI-DIDate2 Jun 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  • Withdrawn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

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, F-OVM-SL17/35
Primary DI / UDI-DI
00819374025607
Basic UDI-DI
081226101OPN058UV
EMDN Code
Z12080202 Oocyte aspiration equipment
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

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

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See all devices from Allwin Medical Devices, Inc. →

Properties

  • 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