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Strataderm

by Stratpharma AG 5 variants

Ref SD005Model Strataderm, Strataderm 5g

Strataderm (SD005) is a Class I device made by Stratpharma AG, registered in EUDAMED on 21 May 2026 (Basic UDI-DI B-07640140193632), 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-07640140193632 Basic UDI-DI Date21 May 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  • Withdrawn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
Strataderm, SD005, Strataderm 5g
Primary DI / UDI-DI
07640140193632, 07640140194349, 07640140190365, 07640140190563
Basic UDI-DI
B-07640140193632, B-07640140194349, B-07640140190365, B-07640140190563
EMDN code
M04040701 Silicone dressings, non-combined
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
Greece
Romania

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.

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Properties

Other properties (12, all answered No)