Skip to content

Acumed

by Acumed LLC 58 variants

Ref 10100053

Acumed (10100053) is a Class I device made by Acumed LLC, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-10806378010217), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10806378010217 Basic UDI-DI 10806378010217UDI-DIDate28 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Instrument
Model / reference
10100053
Primary DI / UDI-DI
10806378010217
Basic UDI-DI
B-10806378010217
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
Device class
Class I
EU registration type
Legacy device (under a directive)
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

  • Sterilise before use
Other properties (13, all answered No)