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IntraUterine Insemination Catheter

by Allwin Medical Devices, Inc 7 variants

Ref F-IUI-OModel IntraUterine Insemination Catheter (Insemina IUI catheter,Insemina IUI catheter-Open Tip,Flexi IUI catheter,Flexi IUI catheter-Open Tip,IUI Curved,Trackable IUI with Malleable Stylet,Trackable IUI catheter-Open Tip,Stumpy IUI Cannula,IUI Catheter

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081226101IUI060SN Basic UDI-DI 00819374022491UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00819374022491 UDI-DI Date18 Sep 2020ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
IntraUterine Insemination Catheter EUDAMED
Flexi Intra Uterine Insemination Catheter Open Tip GUDID
Generic Name
Assisted reproduction transfer catheter/set
Model / Ref / Catalog
IntraUterine Insemination Catheter (Insemina IUI catheter, Insemina IUI catheter-Open Tip, Flexi IUI catheter, Flexi IUI catheter-Open Tip, IUI Curved, Trackable IUI with Malleable Stylet, Trackable IUI catheter-Open Tip, Stumpy IUI Cannula, IUI Catheter, F-IUI-O, Flexi Open Tip
Primary DI / UDI-DI
00819374022491
Basic UDI-DI
081226101IUI060SN
510(k) Number
FDA Product Code
MFD
EMDN Code
U08020199 Assisted reproduction catheters - other
GMDN Term
Assisted reproduction transfer catheter/set
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.5250
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No