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Embryo Transfer Catheter

by Allwin Medical Devices, Inc United States EUDAMEDGUDID

Ref TPEB-ETC-STYModel Embryo Transfer Catheters:(Bulb Trans Star,Bulb Trans Ultra,Echo Trans,Embryo Trans,Pro Echo Trans,Pro Embryo Trans,Twinkle Pro Embryo Trans,Twinkle Embryo Trans, Trial Echo Trans,Trial Embryo Trans), Soft Obturator & Stylet for Embryo Transfer Catheter

Product code MQFEMDN U08020199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081226101ETC059PU Basic UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00819374021753 UDI-DIDate18 Sep 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Trade Name
Embryo Transfer Catheter EUDAMED
Twinkle Pro with Stylet GUDID
Generic Name
Assisted reproduction transfer catheter/set
Model / Ref / Catalog
Embryo Transfer Catheters:(Bulb Trans Star, Bulb Trans Ultra, Echo Trans, Embryo Trans, Pro Echo Trans, Pro Embryo Trans, Twinkle Pro Embryo Trans, Twinkle Embryo Trans, Trial Echo Trans, Trial Embryo Trans), Soft Obturator & Stylet for Embryo Transfer Catheter, TPEB-ETC-STY, TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet
Primary DI / UDI-DI
00819374021753
Basic UDI-DI
081226101ETC059PU
510(k) Number
FDA Product Code
MQF
EMDN Code
U08020199 Assisted reproduction catheters - other
GMDN Term
Assisted reproduction transfer catheter/set
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.6110
Market of Registration
Italy
Commercial Distribution
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

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See all devices from Allwin Medical Devices, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 1203887a-62aa-469e-a913-1594cba26c81 61 fields · synced 25 Oct 2026
  • FDA UDI d2ecf26a-1fc9-4fc6-ac4b-cc656d31fa47 36 fields · synced 30 May 2026