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Acumed

by Acumed LLC 64 variants

Ref 80-4209-SModel ASK Wire

Acumed (80-4209-S) is a Class IIa device made by Acumed LLC, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 0806378BUDI78QP), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0806378BUDI78QP Basic UDI-DI 10806378123825UDI-DIDate22 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
3.5mm Cannulated Drill & 1.3mm K-wire
Model / reference
ASK Wire, 80-4209-S
Primary DI / UDI-DI
10806378123825
Basic UDI-DI
0806378BUDI78QP
EMDN code
P091303 Orthopaedic implant drill bits, single-use
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000023121
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)