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ET Catheter
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 294015Ref 215018Ref 205218Ref 234325Ref 223522Ref 225523Ref 205323Ref 223321Ref 215223Ref 214322Ref 233325Ref 213325Ref 205223Ref 225623Ref 224325Ref 205318Ref 275023Ref 294020Ref 215218Ref 294120Ref 244017Ref 213312Ref 213355Ref 214425Ref 223326
Identity
- Trade Name
- Kitazato ET Catheter Type2-v5 EC-PRO Supported FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- ET Catheter EUDAMED4.7Fr 180mm EC-PRO Supported Inner Catheter FDA UDI
- Model / Reference
- 294015 EUDAMED215018 EUDAMED205218 EUDAMED234325 EUDAMED223522 EUDAMED225523 EUDAMED205323 EUDAMED223321 EUDAMED215223 EUDAMED214322 EUDAMED233325 EUDAMED213325 EUDAMED205223 EUDAMED225623 EUDAMED224325 EUDAMED205318 EUDAMED275023 EUDAMED294020 EUDAMED215218 EUDAMED294120 EUDAMED244017 EUDAMED213312 EUDAMED213355 EUDAMED214425 EUDAMED223326 EUDAMED205118 Type2-v5 EC-PRO Supported FDA UDI
- Description
- 4.7Fr 180mm EC-PRO Supported Inner Catheter FDA UDI
Identifiers
- Catalog Number
- 205118 FDA UDI
- Primary DI / UDI-DI
- 04580303267158 EUDAMED04580303266984 EUDAMED04580303267431 EUDAMED04580303266250 EUDAMED04580303267059 EUDAMED04580303268049 EUDAMED04580303267462 EUDAMED04580303266922 EUDAMED04580303267387 EUDAMED04580303266106 EUDAMED04580303266205 EUDAMED04580303266090 EUDAMED04580303267448 EUDAMED04580303268063 EUDAMED04580303266182 EUDAMED04580303267455 EUDAMED04580303267103 EUDAMED04580303267165 EUDAMED04580303267370 EUDAMED04580303267936 EUDAMED04580303266557 EUDAMED04580745043884 EUDAMED04580745043570 EUDAMED04580303267110 EUDAMED04580745040012 EUDAMED04580303269589 FDA UDI
- Basic UDI-DI
- 458223146ETCHW EUDAMED
- 510(k) Number
- K162878 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 UDIEUDAMED
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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K192540 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K162878 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 458223146ETCHW | 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 (27)
- EUDAMED 6bb09493-a7e2-4e10-8395-4ff737d3f1a0 61 fields · synced Aug 3, 2026
- EUDAMED bd87b111-7c13-440c-b5e5-1b5d8f289427 61 fields · synced May 16, 2026
- EUDAMED f6d07c7f-40ea-4dbf-94dc-223ac796f794 61 fields · synced May 16, 2026
- EUDAMED 79ae308e-6f5d-4ec2-ae4b-5511343ed140 61 fields · synced May 16, 2026
- EUDAMED e046604b-898f-4cfe-aec0-33cc507e538a 61 fields · synced May 16, 2026
- EUDAMED f34d6d40-758b-4cda-8cd5-d03345935e94 61 fields · synced May 16, 2026
- EUDAMED f04e228b-87dd-4358-a504-3044fcaef4ba 61 fields · synced May 17, 2026
- EUDAMED 99284f72-f716-4cff-a739-39048824fc09 61 fields · synced May 17, 2026
- EUDAMED bd5716f2-f72b-4e55-99dd-0fd5c5f8149c 61 fields · synced May 17, 2026
- EUDAMED 3635bb6b-38df-435e-b593-a942bf53dfa4 61 fields · synced May 17, 2026
- EUDAMED 4f4540d7-9944-48e1-81c5-9e4a4ce10d0d 61 fields · synced May 17, 2026
- EUDAMED fe0191f3-d646-49c3-b015-796a87ded493 61 fields · synced May 17, 2026
- EUDAMED bab9083c-0a96-4dd4-aa10-822aa3a10825 61 fields · synced May 17, 2026
- EUDAMED 201cacdd-6184-4a34-bca2-7bf632e5b7c7 61 fields · synced May 18, 2026
- EUDAMED 452f69b1-4708-404c-8d72-f579332e54d1 61 fields · synced May 18, 2026
- EUDAMED c7e4a0d4-7267-49f4-9897-c5b2aac6f064 61 fields · synced May 18, 2026
- EUDAMED cd792f1e-714e-411b-baaf-449d725aed8c 61 fields · synced May 18, 2026
- EUDAMED 1cc27609-8f1e-4bff-921a-18128c2ac4f4 61 fields · synced May 18, 2026
- EUDAMED 41a6bb84-58ab-420c-bdd7-3ae584d6b4da 61 fields · synced May 18, 2026
- EUDAMED 384db052-b68d-4507-9623-84c93e341894 61 fields · synced May 19, 2026
- EUDAMED 6d83cc40-6d00-4f2d-9eb4-9e814b82503c 61 fields · synced May 19, 2026
- EUDAMED f11e9fdf-268f-460f-99c3-2780cdfdb1b7 61 fields · synced May 19, 2026
- EUDAMED 37a1cd13-bae3-481d-9ff0-7dcc5c8cdee6 61 fields · synced May 19, 2026
- EUDAMED 600b1361-11c6-41b5-b985-051d0e86e2d0 61 fields · synced May 19, 2026
- EUDAMED 81af3c7e-5757-414d-83ed-165c93ae78ff 61 fields · synced May 19, 2026
- FDA UDI ddd83fab-3a27-43b7-8c4f-4e7a797424fc 35 fields · synced May 24, 2026
- FDA 510(k) K192540 1 fields · synced May 18, 2026