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Embryo Transfer Catheter
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref PET-ETCModel Embryo Transfer Catheters:(Bulb Trans Star,Bulb Trans Ultra,Echo Trans,Embryo Trans,Pro Echo Trans,Pro Embryo Trans,Twinkle Pro Embryo Trans,Twinkle Embryo Trans, Trial Echo Trans,Trial Embryo Trans), Soft Obturator & Stylet for Embryo Transfer CatheterRef STY23Ref SB-PERef BT-ETC-URef STY18Ref BT-ETC-U-PRef STY-18-OSRef EB-ETC18Ref STY-BURef PET-ETC-STYRef ET-ETC18Ref TPEB-ETC-STYRef PEB-ETCRef BT-ETC-U-S510(k) K200248
Identity
- Trade Name
- EMBRYO TRANSFER CATHETER EUDAMEDEmbryo Trans Embryo Transfer Catheter 18cm FDA UDIBulb Trans Ultra Embryo Transfer Catheter FDA UDIBulb Trans Star Embryo Transfer Catheter - Bulb Tip FDA UDITwinkle Pro with Stylet FDA UDIStylet for Embryo Trans 23cm/ Stylet for Twinkle Embryo Trans 23cm FDA UDIStylet for Embryo Trans/Twinkle Embryo Trans (18cm) FDA UDIStylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter - Bulb Tip FDA UDIPro Embryo Trans FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- EMBRYO TRANSFER CATHETER EUDAMED18cm Catheter FDA UDIBulb Trans Ultra Embryo Transfer Catheter - Bulb Tip FDA UDIBulb Trans Star Embryo Transfer Catheter - Bulb Tip FDA UDITWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet FDA UDIStylet for Embryo Trans and Twinkle Embryo Trans (23cm) FDA UDIStylet for Embryo Trans/Twinkle Embryo Trans (18cm) FDA UDIStylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter - Bulb Tip FDA UDIPRO EMBRYO TRANS - Embryo Transfer Catheter FDA UDI
- Model / Reference
- Embryo Transfer Catheters:(Bulb Trans Star,Bulb Trans Ultra,Echo Trans,Embryo Trans,Pro Echo Trans,Pro Embryo Trans,Twinkle Pro Embryo Trans,Twinkle Embryo Trans, Trial Echo Trans,Trial Embryo Trans), Soft Obturator & Stylet for Embryo Transfer Catheter EUDAMEDPET-ETC EUDAMEDSTY23 EUDAMEDSB-PE EUDAMEDBT-ETC-U EUDAMEDSTY18 EUDAMEDBT-ETC-U-P EUDAMEDSTY-18-OS EUDAMEDEB-ETC18 EUDAMEDSTY-BU EUDAMEDPET-ETC-STY EUDAMEDET-ETC18 EUDAMEDTPEB-ETC-STY EUDAMEDPEB-ETC EUDAMEDBT-ETC-U-S EUDAMEDEmbryo Trans FDA UDIBulb Trans Ultra FDA UDIBulb Trans Star FDA UDITWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet FDA UDIStylet 23cm (Embryo Trans/Twinkle Embryo Trans) FDA UDIStylet for Embryo Trans/Twinkle Embryo Trans (18cm) FDA UDIStylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter FDA UDIPro Embryo Trans ET Catheter FDA UDI
- Description
- 18cm Catheter FDA UDIBulb Trans Ultra Embryo Transfer Catheter - Bulb Tip FDA UDIBulb Trans Star Embryo Transfer Catheter - Bulb Tip FDA UDITWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Stylet FDA UDIStylet for Embryo Trans and Twinkle Embryo Trans (23cm) FDA UDIStylet for Embryo Trans/Twinkle Embryo Trans (18cm) FDA UDIStylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter - Bulb Tip FDA UDIPRO EMBRYO TRANS - Embryo Transfer Catheter FDA UDI
Identifiers
- Catalog Number
- EB-ETC18 FDA UDIBT-ETC-U FDA UDIBT-ETC-U-S FDA UDITPEB-ETC-STY FDA UDISTY23 FDA UDISTY18 FDA UDISTY-BU FDA UDIPEB-ETC FDA UDI
- Primary DI / UDI-DI
- 00812261016771 EUDAMED00812261016566 EUDAMEDFDA UDI00819374023238 EUDAMED00812261016832 EUDAMEDFDA UDI00812261016573 EUDAMEDFDA UDI00819374022309 EUDAMED00819374022101 EUDAMED00812261016559 EUDAMEDFDA UDI00812261016580 EUDAMEDFDA UDI00812261016665 EUDAMED00812261016542 EUDAMED00819374021753 EUDAMEDFDA UDI00819374020572 EUDAMEDFDA UDI00819374021289 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101ETC059PU EUDAMED
- Direct Marketing DI
- 00812261016771 EUDAMED00812261016566 EUDAMED00819374023238 EUDAMED00812261016832 EUDAMED00812261016573 EUDAMED00819374022309 EUDAMED00819374022101 EUDAMED00812261016559 EUDAMED00812261016580 EUDAMED00812261016665 EUDAMED00812261016542 EUDAMED00819374021753 EUDAMED00819374020572 EUDAMED00819374021289 EUDAMED
- 510(k) Number
- K200248 FDA UDI
- FDA Product Code
- MQF 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
- 884.6110 FDA UDI
- Market of Registration
- Spain EUDAMEDCzechia EUDAMEDItaly EUDAMEDNetherlands EUDAMEDDenmark EUDAMEDLithuania EUDAMEDPoland 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
Embryo Transfer Catheter by Allwin Medical Devices, Inc. — 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200248 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081226101ETC059PU | Class I | Active |
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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 (37)
- EUDAMED 203aac19-3ca2-484d-8e95-c484f42a3742 61 fields · synced Sep 17, 2026
- EUDAMED 64c3f347-e824-45d8-bbd5-38f89420f7a0 61 fields · synced May 16, 2026
- EUDAMED b47e5b36-7ba2-429e-9f62-325c103bb3b2 61 fields · synced May 17, 2026
- EUDAMED 8e2be811-2786-4507-81af-8a61d0dd93be 61 fields · synced May 17, 2026
- EUDAMED c41afe54-10c7-480e-9d4a-c46c70761822 61 fields · synced May 17, 2026
- EUDAMED 8bca85ff-9a92-4064-85b4-75ff0c77db49 61 fields · synced May 17, 2026
- EUDAMED 37e82282-7126-4ee7-9438-4d54e9ef9d58 61 fields · synced May 17, 2026
- EUDAMED 1808da0c-5056-44e9-bd68-ce2fded8d514 61 fields · synced May 17, 2026
- EUDAMED 142e5643-7e3f-4d20-8005-9a4c47f54a26 61 fields · synced May 18, 2026
- EUDAMED 2f8c2f86-e3b3-4913-9d54-f628375830d4 61 fields · synced May 18, 2026
- EUDAMED 0fd74765-a894-46ee-9643-cdafa604f09f 61 fields · synced May 18, 2026
- EUDAMED 1203887a-62aa-469e-a913-1594cba26c81 61 fields · synced May 19, 2026
- EUDAMED 5e25e0bd-c2de-4bf0-8ff5-bb5957f951aa 61 fields · synced May 19, 2026
- EUDAMED 699ffa05-03de-4ca5-b90a-9fa623cf144e 85 fields · synced May 19, 2026
- FDA UDI 8671eb0f-e568-4166-9fc9-d7b0b2d816aa 36 fields · synced May 22, 2026
- FDA UDI ac17fcca-8353-40f7-9a5a-62b9d28a110b 36 fields · synced May 30, 2026
- FDA UDI e8a2ab52-3785-4911-9003-fed4ce1eff1c 36 fields · synced May 30, 2026
- FDA UDI d2ecf26a-1fc9-4fc6-ac4b-cc656d31fa47 36 fields · synced May 30, 2026
- FDA UDI 000c9a9e-b7e0-4328-b21d-843f47bdc962 36 fields · synced May 30, 2026
- FDA UDI 480fa26e-9426-455f-8ffe-9e83c9d6dbf0 36 fields · synced May 30, 2026
- FDA UDI 839f57ea-e7e5-4e4a-b078-d4368103cba5 35 fields · synced May 30, 2026
- FDA UDI 71f515bf-9c31-4298-8633-6ef8cfe81d1c 36 fields · synced May 30, 2026
- EUDAMED f228e028-e2c7-4390-8542-705173f052b2 61 fields · synced Jun 19, 2026
- EUDAMED aeae4d82-f7f3-4f1b-a0cd-1e24b8a6fe95 61 fields · synced Jul 9, 2026
- EUDAMED f7ea9d4e-3f0f-4155-ac8e-6057b49b80b8 61 fields · synced Jul 10, 2026
- EUDAMED 3b34f106-ce1b-4853-8724-20d816e49feb 61 fields · synced Jul 12, 2026
- EUDAMED a3d560be-0950-4eb3-90b5-ef8939a9ca95 61 fields · synced Jul 14, 2026
- EUDAMED 3b381b8d-6032-4544-babb-afc171695f3d 61 fields · synced Jul 15, 2026
- EUDAMED c4f2aa83-b424-4176-be2b-b98ba61bdda0 61 fields · synced Jul 17, 2026
- EUDAMED a91edade-0914-4665-ab77-33ac6e930103 61 fields · synced Jul 20, 2026
- EUDAMED d919342e-c9ab-438f-9a00-9359440e07d2 61 fields · synced Jul 24, 2026
- EUDAMED e77023d1-2a7f-4512-9ada-fb21757bb07f 61 fields · synced Jul 24, 2026
- EUDAMED 3b193002-5871-49d3-9754-1bce82741ac3 61 fields · synced Jul 28, 2026
- EUDAMED 72fc8834-9f39-435d-9b09-b2fb3c3309ba 61 fields · synced Jul 29, 2026
- EUDAMED 45fbf8f3-edd1-4e01-b0b6-ebdd00caf8b4 61 fields · synced Jul 31, 2026
- EUDAMED 8c57728d-924a-4004-acf3-0aa7f5a7f0d5 61 fields · synced Sep 17, 2026
- FDA 510(k) K200248 1 fields · synced Jun 9, 2026