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MatrixPRO II Driver

by Pro-Dex, Inc.

Ref 05.000.030Model APD-1000-2

MatrixPRO II Driver (05.000.030) is a device classified as Class IIa in the EU and Class I in the US made by Pro-Dex, Inc., registered in EUDAMED on 5 Apr 2022 (Basic UDI-DI 0856482008APD-1000-XRU) and listed in FDA GUDID since 12 Mar 2020 (UDI-DI 00856482008023), active as of 22 Oct 2026.

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

CE MDR 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number0856482008APD-1000-XRU Basic UDI-DI 00856482008023UDI-DIDate5 Apr 2022RegisteredStatusActive
European UnionCE/MDR EUDAMED Number0856482008APD-1000-XRU Basic UDI-DI 00856482008023UDI-DIDate5 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00856482008023 UDI-DI Date12 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0856482008APD-1000-XRU registered 5 Apr 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00856482008023 listed 12 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00856482008023
  2. Registered EUDAMED 0856482008APD-1000-XRU

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MatrixPRO II Driver EUDAMED
Matrix Pro II Driver GUDID
Generic name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Model / reference
APD-1000-2, 05.000.030
Primary DI / UDI-DI
00856482008023
Basic UDI-DI
0856482008APD-1000-XRU, B-00856482008023
Direct marketing DI
00856482008023
FDA product code
HWE, GXL, GEY
EMDN code
L26, Z12130503
GMDN term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820, 882.4900
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Manufacturer details

EUDAMED SRN
US-MF-000010685
Authorised representative
Eurolink Europe Compliance Limited IE-AR-000002852

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGICAL DRILLS.

Other devices from Pro-Dex, Inc.

See all devices from Pro-Dex, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (20, all answered No)