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BRM TOOL SCREWS INSTRUMENT K-Wire Ø 2.5 x 200 mm

by Brm Extremities

Ref STOIKW25200010N

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805771755FT09B5CB Basic UDI-DI 08053782781010UDI-DIDate11 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08053782781010 UDI-DI Date15 Oct 2025ListedStatusListed 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.

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  • Withdrawn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
K-Wire Ø 2.5 x 200 mm EUDAMED
Brm Tool Screws Instrument GUDID
Generic Name
Orthopaedic guidewire, single-use
Device Name
Fili di Kirschner
Model / Ref / Catalog
STOIKW25200010N, K-Wire Ø 2.5 x 200 mm
Primary DI / UDI-DI
08053782781010
Basic UDI-DI
805771755FT09B5CB
Unit of Use DI
18053782781017
FDA Product Code
LXH
EMDN Code
P09120301 Kirschner bone wires
GMDN Term
Orthopaedic guidewire, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
STOIKW25200010N
GUDID
K-Wire Ø 2.5 x 200 mm
Device ClassEUDAMED
Class IIa
GUDID
Class I

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No