Wortie Freeze Pro

by Oystershell NV 3 variants

Ref 07011541Model X92001686

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number5410765PixieCO2FQ Basic UDI-DI 05410765005694UDI-DI	Date21 Nov 2025Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Pixie CO2
Model / Reference: X92001686, 07011541

Primary DI / UDI-DI: 05410765005694
Basic UDI-DI: 5410765PixieCO2FQ
EMDN Code: M9001 Cryotherapy and thermotherapy devices

Device Class: Class IIa
EU market of registration: Sweden

Manufacturer details

EUDAMED SRN: BE-MF-000011797

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Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No