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MatrixPRO Driver

by Pro-Dex, Inc.

Ref 05.000.020Model SYN-1000

MatrixPRO Driver (05.000.020) 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 21 Apr 2025 (Basic UDI-DI B-00862377000102) and listed in FDA GUDID since 27 Mar 2020 (UDI-DI 00862377000102), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00862377000102 Basic UDI-DI 00862377000102UDI-DIDate21 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00862377000102 UDI-DI Date27 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00862377000102 registered 21 Apr 2025 Active
  • FDA GUDID UDI-DI 00862377000102 listed 27 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00862377000102
  2. Registered EUDAMED B-00862377000102

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  • Withdrawn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
MatrixPRO Driver EUDAMED
MatrixPRO Driver Handpiece EUDAMEDGUDID
Generic name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Model / reference
SYN-1000, 05.000.020
Primary DI / UDI-DI
00862377000102
Basic UDI-DI
B-00862377000102, 0856482008SYN-1000SC
FDA product code
GEY, GXL
EMDN code
L26 Surgical screwdrivers, reusable
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
Legacy device (under a directive)
Standard device
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

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under SURGICAL SCREWDRIVERS, REUSABLE.

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
  • Manufacturing date
Other properties (19, all answered No)