Skip to content

INT, FirstWire GW351BJF

by Shanghai Kindly Medical Instruments Co., Ltd.

Ref GW351BJFModel 0.018", 0.021", 0.025", 0.028", 0.032", 0.035", 0.038"

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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
European UnionCE/MDR EUDAMED Number69509009CEAGWMN Basic UDI-DI 06950900961502UDI-DIDate24 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06950900961502 UDI-DI Date18 Aug 2023ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
INT, FirstWire
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Device Name
Guidewire
Model / Reference
GW351BJF, 0.018", 0.021", 0.025", 0.028", 0.032", 0.035", 0.038"
Primary DI / UDI-DI
06950900961502
Basic UDI-DI
69509009CEAGWMN
510(k) Number
FDA Product Code
DQX
EMDN Code
C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1330
EU market of registration
Slovakia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K180177)

Show all (12)

Other devices from Shanghai Kindly Medical Instruments Co., Ltd.

See all devices from Shanghai Kindly Medical Instruments Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Implantable: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No