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Tondaus Surgical Skin Marker

by Dongguan Tondaus Meditech Co., Ltd. 42 variants

Ref TF01NS, TS02NS, R04, R03, TR02NS, EV06, B05, DR, D04, RT3000, EV09, D02, EV08, W04, EV05, DV, TR01NS, DW, TF04NS, B03, DE, TS05, TF04, TF02NS, D03, D07, B09, EV02, D01, TS01NS, W01, EV03

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697180265SSMU2 Basic UDI-DI Date17 Apr 2026RegisteredStatusActive
European UnionCE/MDR Number697180265SSMU2 Basic UDI-DI Date17 Apr 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
Tondaus Surgical Skin Marker
Surgical Skin Marker
Model / Reference
TF01NS, TS02NS, R04, R03, TR02NS, EV06, B05, DR, D04, RT3000, EV09, D02, EV08, W04, EV05, DV, TR01NS, DW, TF04NS, B03, DE, TS05, TF04, TF02NS, D03, D07, B09, EV02, D01, TS01NS, W01, EV03
Primary DI / UDI-DI
06971802651124, 06971802651179, 06971802655184, 06971802655177, 06971802650981, 06971802650509, 06971802651070, 06971802651346, 06971802655092, 06971802651872, 06971802655047, 06971802655061, 06971802655030, 06971802651223, 06971802650493, 06971802651322, 06971802650127, 06971802651353, 06971802651155, 06971802651056, 06971802651360, 06971802650257, 06971802655016, 06971802651131, 06971802655078, 06971802655122, 06971802651117, 06971802650462, 06971802655054, 06971802651162, 06971802651193, 06971802650479
Basic UDI-DI
697180265SSMU2, 697180265SSSMRJ, B-06971802650257
EMDN Code
V9004 Skin marking dermographic pencils and pens
Device Class
Class I
EU market of registration
Germany
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000023652
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Dongguan Tondaus Meditech Co., Ltd.

See all devices from Dongguan Tondaus Meditech Co., Ltd. →

Properties

  • Sterile NoEUDAMEDYesEUDAMED

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No