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Topivac

by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 6 variants

Ref TOPIVAC TOPI T-NPWTModel Topivac

Topivac (TOPIVAC TOPI T-NPWT) is a Class IIa device made by Amedus Medi̇kal Uygulamalar Sağlik Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 868316111TOPIM3), active as of 7 Nov 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number868316111TOPIM3 Basic UDI-DI Date3 Nov 2026RegisteredStatusActive
European UnionCE/MDR Number868316111TOPIM3 Basic UDI-DI Date3 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device name
Topi A100 Mobile Disposable Classic NPWT Vacuum Assisted Wound Care Therapy Device
Topi A200 Mobile Disposable Incission NPWT Vacuum Assisted Wound Care Therapy Device
Model / reference
Topivac, TOPIVAC TOPI T-NPWT
Primary DI / UDI-DI
08683161110010, 08683161110027
Basic UDI-DI
868316111TOPIM3, B-08683161110027
Direct marketing DI
08683161110010
08683161110027
EMDN code
Z12019003 Wound treatment equipment
Device class
Class IIa
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Lithuania

Manufacturer details

EUDAMED SRN
TR-MF-000016889

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

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Properties

Other properties (14, all answered No)