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Ectocare

by PolarSeal Tapes and Conversions Ltd 6 variants

Ref 321-050Model 321-050 Manuka IG Max pouch 5.1x5.1cm

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060419550249 Basic UDI-DI 05060419550249UDI-DIDate4 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
321-050 Manuka IG Max pouch 5.1x5.1cm
Model / Reference
321-050 Manuka IG Max pouch 5.1x5.1cm, 321-050
Primary DI / UDI-DI
05060419550249
Basic UDI-DI
B-05060419550249
EMDN Code
M040204 Non-adherent absorbent dressings
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000029062
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Polarseal Tapes and Conversions

See all devices from Polarseal Tapes and Conversions →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No