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Temrex

by Temrex Corporation 2 variants

Ref 103-107

Temrex (103-107) is a Class I device made by Temrex Corp., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00850015110528), 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-00850015110528 Basic UDI-DI 00850015110528UDI-DIDate27 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  • Withdrawn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
Matrix Rolls
Model / reference
103-107
Primary DI / UDI-DI
00850015110528
Basic UDI-DI
B-00850015110528
EMDN code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018366
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY.

Other devices from Temrex Corp.

See all devices from Temrex Corp. →

Properties

Other properties (12, all answered No)