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GramaDerm

by Oculus Technologies of México S.A. de C.V.

Ref P-E112T00, P-E732T00

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07503006698811 Basic UDI-DI Date17 Dec 2021RegisteredStatusActive

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  • Withdrawn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
GramaDerm Combo-Pack
Model / Reference
P-E112T00, P-E732T00
Primary DI / UDI-DI
07503006698811, 07502273996019
Basic UDI-DI
B-07503006698811, B-07502273996019
EMDN Code
M04040501 Hydrogel dressings, non-combined
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
MX-MF-000013827
Authorised representative
Sonoma Pharmaceuticals Netherlands B.V NL-AR-000013244

Other devices from Oculus Technologies of México S.A. de C.V.

See all devices from Oculus Technologies of México S.A. de C.V. →

Properties

Other properties (11)

  • Sterile: No
  • 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