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COMSfix

by Piomic Medical AG

Ref 01.0002

COMSfix (01.0002) is a medical device (EU MDR Class I; EMDN category wound treatment equipment) made by Piomic Medical AG, registered in EUDAMED on 4 Jun 2026 (Basic UDI-DI 764029615002DU), active as of 24 Oct 2026.

Active European Union

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764029615002DU Basic UDI-DI Date4 Jun 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device name
Single-use Strap
Model / reference
01.0002
Primary DI / UDI-DI
07640296150046, 07640296150053
Basic UDI-DI
764029615002DU
EMDN code
Z12019003 Wound treatment equipment
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CH-MF-000013391
Authorised representative
EUMEDIQ GmbH DE-AR-000007809

Similar devices in this category

Other devices filed under WOUND TREATMENT EQUIPMENT.

Other devices from Piomic Medical AG

Properties

Other properties (14, all answered No)