Identity
- Device Name
- IUI Catheter EUDAMED
- Model / Reference
- 131181 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04580303266656 EUDAMED
- Basic UDI-DI
- 458223146IUIJZ EUDAMED
- EMDN Code
- U08020101 CATHETERS FOR INSEMINATION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
IUI Catheter by Kitazato Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162667 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 458223146IUIJZ | Class I | Active |
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Manufacturer
- Manufacturer
- Kitazato Corporation
- EUDAMED SRN
- JP-MF-000018374
- Authorised Representative
- BIOMEDICAL SUPPLY, S.L. ES-AR-000014358
Sources (2)
- EUDAMED 87c37a28-bef6-450f-810e-11d6db88005d 85 fields · synced Jun 18, 2026
- FDA 510(k) K162667 1 fields · synced May 18, 2026