Skip to content

Acumed 80-0318-S

by Acumed LLC

Ref 80-0318-S

Acumed 80-0318-S is a device classified as Class IIa in the EU and Class I in the US made by Acumed LLC, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-10806378114038) and listed in FDA GUDID since 10 Jun 2019 (UDI-DI 10806378114038), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10806378114038 Basic UDI-DI 10806378114038UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378114038 UDI-DI Date10 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10806378114038 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 10806378114038 listed 10 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10806378114038
  2. Registered EUDAMED B-10806378114038

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Acu-Loc 2 EUDAMED
Acumed GUDID
Generic name
Fluted surgical drill bit, single-use
Device name
Drill
Model / reference
80-0318-S
Primary DI / UDI-DI
10806378114038
Basic UDI-DI
B-10806378114038
FDA product code
HTW
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fluted surgical drill bit, single-use

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)