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Embryo Transfer Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref TPEB-ETC-SBModel 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
Identity
- Trade Name
- EMBRYO TRANSFER CATHETER EUDAMEDTwinkle Pro with Soft Obturator FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- EMBRYO TRANSFER CATHETER EUDAMEDTWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator 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 EUDAMEDTPEB-ETC-SB EUDAMEDTWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator FDA UDI
- Description
- TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator FDA UDI
Identifiers
- Catalog Number
- TPEB-ETC-SB FDA UDI
- Primary DI / UDI-DI
- 00819374021852 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101ETC059PU EUDAMED
- Direct Marketing DI
- 00819374021852 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
- Lithuania 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 — 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 | 081226101ETC059PU | 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 (3)
- EUDAMED 4c02f7cb-b20e-4e38-a105-78ee6da17fc1 61 fields · synced Jun 17, 2026
- FDA UDI d9fed2cc-4356-45dc-a6c5-0b96d112e3ad 36 fields · synced May 30, 2026
- EUDAMED 43ed805c-48b3-4561-957d-491377302808 61 fields · synced Jun 11, 2026