Identity
- Trade Name
- Kitazato ET Catheter FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- ET Catheter EUDAMED3Fr 400mm Catheter, Guide with obturator FDA UDI
- Model / Reference
- 223340 EUDAMED223340 Type2-v5 FDA UDI
- Description
- 3Fr 400mm Catheter, Guide with obturator FDA UDI
Identifiers
- Catalog Number
- 223340 FDA UDI
- Primary DI / UDI-DI
- 04580303266144 EUDAMEDFDA UDI
- Basic UDI-DI
- 458223146ETCHW EUDAMED
- 510(k) Number
- K192540 FDA UDI
- FDA Product Code
- MQF FDA UDI
- EMDN Code
- U08020102 CATHETERS FOR EMBRYO TRANSFER EUDAMED
- GMDN Term
- Assisted reproduction transfer catheter/set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6110 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ET Catheter by Kitazato Corporation — 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 | 458223146ETCHW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 b2d2ec83-1def-4e4c-8d0d-e042242676fb 61 fields · synced Jun 6, 2026
- FDA UDI eeaf7f0d-a050-41d2-9d84-66cacd36d324 35 fields · synced May 30, 2026