Identity
- Trade Name
- WORTIE KRIO PRO EUDAMED
- Device Name
- Pixie CO2 EUDAMED
- Model / Reference
- X92001686 EUDAMED07011759 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05410765009654 EUDAMED
- Basic UDI-DI
- 5410765PixieCO2FQ EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Wortie Krio Pro by Oystershell NV — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5410765PixieCO2FQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oystershell NV
- EUDAMED SRN
- BE-MF-000011797
Sources (1)
- EUDAMED 98a86778-e0ef-4d47-b2be-29b4a466f63b 61 fields · synced Jun 19, 2026