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Stratamark

by Stratpharma AG 2 variants

Ref SK050Model Stratamark 50g

Stratamark (SK050) is a Class I device made by Stratpharma AG, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-07640140193601), 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-07640140193601 Basic UDI-DI Date22 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  • Withdrawn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

Model / reference
Stratamark 50g, SK050
Primary DI / UDI-DI
07640140193601, 07640140191652, 07640140190525
Basic UDI-DI
B-07640140193601, B-07640140191652, B-07640140190525
EMDN code
M04040701 Silicone dressings, non-combined
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000030606
Authorised representative
Freyr Regulatory GmbH DE-AR-000047121

Similar devices in this category

Other devices filed under SILICONE DRESSINGS, NON-COMBINED.

Other devices from Stratpharma AG

See all devices from Stratpharma AG →

Properties

Other properties (12, all answered No)