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Endwarts Freeze

by Oystershell NV 3 variants

Part of a family of 10 devices: see the family page

Ref 07011674Model X92001627 + X92001667

Endwarts Freeze (07011674) is a Class IIa device made by Oystershell NV, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 5410765PixieN2OGK), active as of 23 Oct 2026.

Active European Union

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5410765PixieN2OGK Basic UDI-DI 05410765008381UDI-DIDate25 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Pixie NO2, Pixie NO2 XL
Model / reference
X92001627 + X92001667, 07011674
Primary DI / UDI-DI
05410765008381
Basic UDI-DI
5410765PixieN2OGK
EMDN code
M9001 Cryotherapy and thermotherapy devices
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
BE-MF-000011797

Related devices

Category: Hot/cold therapy pack, reusable

Similar devices in this category

Other devices filed under CRYOTHERAPY AND THERMOTHERAPY DEVICES.

Other devices from Oystershell NV

See all devices from Oystershell NV →

Properties

Other properties (14, all answered No)