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IntraUterine Insemination Catheter

EUDAMEDFDA UDI

Class I (EU MDR)

Ref T-IUIModel 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 CatheterRef I-IUI-C-ORef F-IUI-ORef F-IUIRef ST-IUI

by Allwin Medical Devices, Inc

Identity

Trade Name
IntraUterine Insemination Catheter EUDAMED
Curved Insemina Intra Uterine Insemination Catheter Open Tip FDA UDI
Flexi Intra Uterine Insemination Catheter FDA UDI
Trackable Intra Uterine Insemination Catheter FDA UDI
Stumpy Intra Uterine Insemination Cannula FDA UDI
Flexi Intra Uterine Insemination Catheter Open Tip FDA UDI
Generic Name
Assisted reproduction transfer catheter/set FDA UDI
Device Name
INTRAUTERINE INSEMINATION CATHETER EUDAMED
Model / Reference
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 EUDAMED
T-IUI EUDAMED
I-IUI-C-O EUDAMED
F-IUI-O EUDAMED
F-IUI EUDAMED
ST-IUI EUDAMED
Curved Insemina Open Tip FDA UDI
Flexi FDA UDI
Trackable FDA UDI
Stumpy FDA UDI
Flexi Open Tip FDA UDI

Identifiers

Catalog Number
I-IUI-C-O FDA UDI
F-IUI FDA UDI
T-IUI FDA UDI
ST-IUI FDA UDI
F-IUI-O FDA UDI
Primary DI / UDI-DI
00812261016863 EUDAMEDFDA UDI
00819374021890 EUDAMEDFDA UDI
00819374022491 EUDAMEDFDA UDI
00812261016825 EUDAMEDFDA UDI
00812261016610 EUDAMEDFDA UDI
Basic UDI-DI
081226101IUI060SN EUDAMED
Direct Marketing DI
00812261016863 EUDAMED
00819374021890 EUDAMED
00819374022491 EUDAMED
00812261016825 EUDAMED
510(k) Number
K190522 FDA UDI
FDA Product Code
MFD FDA UDI
EMDN Code
U08020199 ASSISTED REPRODUCTION CATHETERS - OTHER EUDAMED
GMDN Term
Assisted reproduction transfer catheter/set FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
884.5250 FDA UDI
Market of Registration
Spain EUDAMED
Czechia EUDAMED
Denmark EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

IntraUterine Insemination Catheter by Allwin Medical Devices, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allwin Medical Devices, Inc
EUDAMED SRN
US-MF-000011349
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (14)

  • EUDAMED 19550564-6cee-46d6-97ad-681aff85614b 61 fields · synced Sep 18, 2026
  • EUDAMED 4acf0df8-988a-4484-9fe6-e267343b9469 61 fields · synced May 17, 2026
  • EUDAMED 23e7de91-709c-4639-adc2-b12f18bcd220 61 fields · synced May 17, 2026
  • EUDAMED 6782882d-d816-457c-8665-16d0e75cff08 61 fields · synced May 18, 2026
  • FDA UDI 76d61fef-1454-4623-bbc8-bdd61a2c1fc6 34 fields · synced May 29, 2026
  • FDA UDI 0cb1976b-b95c-450a-a03f-c03bc1a676e7 35 fields · synced May 30, 2026
  • FDA UDI e694d873-54b4-42e8-82ea-68063fa99574 35 fields · synced May 30, 2026
  • FDA UDI d0b1fd3f-f428-46dc-90a3-354652ec7f58 35 fields · synced May 30, 2026
  • FDA UDI db1da6b2-8c0d-4479-8a0b-a9c78e99ffe4 35 fields · synced May 30, 2026
  • EUDAMED 8b4aa405-02b0-4431-abd0-b339bfa39f62 61 fields · synced Jun 20, 2026
  • EUDAMED 69a5fd64-fa3d-4fe2-a848-a08de9ade384 61 fields · synced Jul 9, 2026
  • EUDAMED 00875252-212b-4fc6-b8ef-2fb8460c56d4 61 fields · synced Jul 20, 2026
  • EUDAMED 86a75c1d-49d3-4e58-9fdd-512c1b26f403 61 fields · synced Aug 1, 2026
  • EUDAMED e06b46e5-56d1-4c05-a0c4-56f0f9bba296 61 fields · synced Sep 18, 2026