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IntraUterine Insemination Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref I-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
Identity
- Trade Name
- IntraUterine Insemination Catheter EUDAMEDInsemina Open Tip Intra Uterine Insemination Catheter 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 EUDAMEDI-IUI-O EUDAMEDInsemina Open Tip FDA UDI
Identifiers
- Catalog Number
- I-IUI-O FDA UDI
- Primary DI / UDI-DI
- 00819374021814 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101IUI060SN EUDAMED
- Direct Marketing DI
- 00819374021814 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5250 FDA UDI
- Market of Registration
- Netherlands 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081226101IUI060SN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED 406903a4-f54f-4855-a2eb-1356834fbb41 61 fields · synced May 30, 2026
- FDA UDI d0b18b0f-a0a4-4e33-b053-a02c72b9ec30 35 fields · synced May 30, 2026