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Stone Baskets & Extractors

EUDAMED

Class IIa (EU MDR)

Ref U-P8/38Model Nitiflex Nitinol Stone Basket-Flatwire&Helical,GRAB-IT SS Stone Basket–Flatwire&Helical,Trapper No Tip Nitinol Stone Basket,Maestro Nitinol Tipless Stone Basket,Elite Stone Retriever,GRASP-IT Three Prong Grasping Forcep,U-PERC Nitinol Stone Basket

by Allwin Medical Devices, Inc

Identity

Trade Name
STONE BASKETS & EXTRACTORS EUDAMED
Device Name
STONE BASKETS & EXTRACTORS EUDAMED
Model / Reference
Nitiflex Nitinol Stone Basket-Flatwire&Helical,GRAB-IT SS Stone Basket–Flatwire&Helical,Trapper No Tip Nitinol Stone Basket,Maestro Nitinol Tipless Stone Basket,Elite Stone Retriever,GRASP-IT Three Prong Grasping Forcep,U-PERC Nitinol Stone Basket EUDAMED
U-P8/38 EUDAMED

Identifiers

Primary DI / UDI-DI
00812261014951 EUDAMED
Basic UDI-DI
081226101SBE018PC EUDAMED
EMDN Code
U090101 URINARY STONE RETRIEVAL BASKETS 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

Stone Baskets & Extractors 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 (1)

  • EUDAMED 13cdb1bf-6fbd-4963-94f1-44773b88e0f7 61 fields · synced Jul 12, 2026