Endwarts Freeze
Part of a family of 10 devices: see the family page
Ref 07011668Model X92001627 + X92001667
Endwarts Freeze (07011668) is a Class IIa device made by Oystershell NV, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 5410765PixieN2OGK), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5410765PixieN2OGK 05410765008329 | Date25 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 5410765PixieN2OGK
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Pixie NO2, Pixie NO2 XL
- Model / reference
- X92001627 + X92001667, 07011668
- Primary DI / UDI-DI
- 05410765008329
- Basic UDI-DI
- 5410765PixieN2OGK
- EMDN code
- M9001 Cryotherapy and thermotherapy devices
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- BE-MF-000011797
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