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Embryo Transfer Catheter
EUDAMEDClass I (EU MDR)
Ref STY23-OSModel 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 EUDAMED
- Device Name
- EMBRYO TRANSFER CATHETER EUDAMED
- 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 EUDAMEDSTY23-OS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00819374022026 EUDAMED
- Basic UDI-DI
- 081226101ETC059PU EUDAMED
- Direct Marketing DI
- 00819374022026 EUDAMED
- EMDN Code
- U08020199 ASSISTED REPRODUCTION CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Embryo Transfer Catheter by Allwin Medical Devices, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 7f79a336-6594-464c-a005-9a56a34ba848 61 fields · synced Jun 18, 2026