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Breast Lesion Localization Wire

by Zhejiang CuraWay Medical Technology Co., Ltd. 54 variants

Ref GW-J 20-97

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970467339576 UDI-DI Date22 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697046733GW2U Basic UDI-DI 06970467339576UDI-DIDate14 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Curaway
Generic Name
Radiological image marker, implantable
Model / Reference
GW-J 20-97
Primary DI / UDI-DI
06970467339576 EUDAMED
06937278655004 GUDID
Basic UDI-DI
697046733GW2U
FDA Product Code
FZX
EMDN Code
A019012 Breast nodules and other structures localisation needles and systems
GMDN Term
Radiological image marker, implantable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06970467339576
GUDID
06937278655004
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
CN-MF-000025983
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Zhejiang CuraWay Medical Technology Co., Ltd.

See all devices from Zhejiang CuraWay Medical Technology Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No