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Embryo Transfer Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref PEB-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 EUDAMEDPro Embryo Trans with Soft Obturator FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- EMBRYO TRANSFER CATHETER EUDAMEDPRO 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 EUDAMEDPEB-ETC-SB EUDAMEDPro Embryo Trans with Soft Obturator FDA UDI
- Description
- PRO EMBRYO TRANS- Embryo Transfer Catheter with Soft Obturator FDA UDI
Identifiers
- Catalog Number
- PEB-ETC-SB FDA UDI
- Primary DI / UDI-DI
- 00812261016849 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101ETC059PU EUDAMED
- Direct Marketing DI
- 00812261016849 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
- Netherlands 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 3a184bc0-9ed6-4a33-8b71-217d06542185 61 fields · synced Jun 18, 2026
- FDA UDI 88469add-86d0-4254-9353-22528a1e5334 36 fields · synced May 30, 2026
- EUDAMED 6424551a-401c-4940-99c0-99e1e3214b64 61 fields · synced Jun 18, 2026