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Wortie Freeze Pro
EUDAMEDClass IIa (EU MDR)
Ref 07011754Model X92001686Ref 07011540Ref 07011541
Identity
- Trade Name
- WORTIE FREEZE PRO EUDAMED
- Device Name
- Pixie CO2 EUDAMED
- Model / Reference
- X92001686 EUDAMED07011754 EUDAMED07011540 EUDAMED07011541 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05410765009616 EUDAMED05410765005687 EUDAMED05410765005694 EUDAMED
- Basic UDI-DI
- 5410765PixieCO2FQ EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Iceland EUDAMEDBelgium EUDAMEDSweden 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 Freeze Pro by Oystershell NV — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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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 (3)
- EUDAMED 29e22c66-8eec-4d13-adad-749e94aa1d01 61 fields · synced Jul 28, 2026
- EUDAMED fe6ed103-f275-4d8f-b872-02ea58b16d48 61 fields · synced May 18, 2026
- EUDAMED caacc378-9b3e-4f92-aa78-bf020281a1f8 61 fields · synced May 19, 2026