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NephroTrack Nephrostomy Track Balloon Dilator
EUDAMEDClass IIa (EU MDR)
Ref NTAM10/12-IDAModel UreTrack Ureteral Balloon Dilator(With inflation device),NephroTrack Nephrostomy Track Balloon Dilator(with Inflation Device,with Amplatz and Inflation Device,with Amplatz Sheath)
Identity
- Trade Name
- NephroTrack Nephrostomy Track Balloon Dilator EUDAMED
- Device Name
- BALLOON DILATOR EUDAMED
- Model / Reference
- UreTrack Ureteral Balloon Dilator(With inflation device),NephroTrack Nephrostomy Track Balloon Dilator(with Inflation Device,with Amplatz and Inflation Device,with Amplatz Sheath) EUDAMEDNTAM10/12-IDA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812261014258 EUDAMED
- Basic UDI-DI
- 081226101BDR009KX EUDAMED
- Direct Marketing DI
- 00812261014258 EUDAMED
- EMDN Code
- U030202 URETERAL DILATORS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa 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
NephroTrack Nephrostomy Track Balloon Dilator by Allwin Medical Devices, Inc. — Class IIa — 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 | 081226101BDR009KX | Class IIa | 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 649078fe-81d9-4d11-acd2-5290d0e87a4e 61 fields · synced Jun 17, 2026