Identity
- Trade Name
- ENDWARTS EXTRA EUDAMED
- Device Name
- Pixie Skin Tag EUDAMED
- Model / Reference
- X92001673 EUDAMED07011687 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05410765008510 EUDAMED
- Basic UDI-DI
- 5410765PixieSkinTagSM EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Endwarts Extra 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 | 5410765PixieSkinTagSM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oystershell NV
- EUDAMED SRN
- BE-MF-000011797
Sources (1)
- EUDAMED 03e9b549-f359-4263-94b2-34f53536fffe 61 fields · synced Jul 28, 2026