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Trumatch SD980.028

by Materialise NV

Ref SD980.028

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243637

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54200603B0011SR Basic UDI-DI 05420060380747UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05420060380747 UDI-DI Date28 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243637 Date21 Feb 2025DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 7 Nov 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
TruMatch CMF Titanium 3D Printed Guides EUDAMED
Trumatch GUDID
Generic name
Custom-made orthopaedic/craniofacial surgical guide
Model / Ref / Catalog
SD980.028
Primary DI / UDI-DI
05420060380747
Basic UDI-DI
54200603B0011SR
510(k) Number
FDA product code
DZJ, LLZ
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Custom-made orthopaedic/craniofacial surgical guide
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.4120, 892.2050
EU registration type
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 II

Related devices

Category: Custom-made orthopaedic/craniofacial surgical guide

Cleared under the same submission (K243637)

Show all (12)

Other devices from Materialise NV

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number

Other properties (21)

  • Supplied sterile: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No