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NephroTrack Nephrostomy Track Balloon Dilator

EUDAMED

Class IIa (EU MDR)

Ref NT10/12Model UreTrack Ureteral Balloon Dilator(With inflation device),NephroTrack Nephrostomy Track Balloon Dilator(with Inflation Device,with Amplatz and Inflation Device,with Amplatz Sheath)

by Allwin Medical Devices, Inc

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) EUDAMED
NT10/12 EUDAMED

Identifiers

Primary DI / UDI-DI
00812261012698 EUDAMED
Basic UDI-DI
081226101BDR009KX EUDAMED
Direct Marketing DI
00812261012698 EUDAMED
EMDN Code
U030202 URETERAL DILATORS, WITH BALLOON EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Romania 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

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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 (2)

  • EUDAMED 296097ec-8ab8-4a56-8ab5-fcb984bd6644 61 fields · synced Jul 9, 2026
  • EUDAMED 306fee72-0df2-4db2-bbda-d25ea0c8bc47 61 fields · synced Jul 9, 2026