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StrataXRT

by Stratpharma AG 5 variants

Ref SX050Model StrataXRT 50g

StrataXRT (SX050) is a Class IIa device made by Stratpharma AG, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-07640140190464), 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 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 NumberB-07640140190464 Basic UDI-DI Date30 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
StrataXRT 50g, SX050
Primary DI / UDI-DI
07640140190464, 07640140191881, 07640140193120, 07640140192796
Basic UDI-DI
B-07640140190464, B-07640140191881, B-07640140193120, B-07640140192796
EMDN code
M04040701 Silicone dressings, non-combined
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
Spain
Romania
Greece

Manufacturer details

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

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Other devices filed under SILICONE DRESSINGS, NON-COMBINED.

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Properties

Other properties (12, all answered No)