Identity
- Trade Name
- POP UNIVERSAL EUDAMED
- Device Name
- PURIST Leg Positioning System EUDAMED
- Model / Reference
- 6813402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701602300211 EUDAMED
- Basic UDI-DI
- 037016023DT008PURISTAK EUDAMED
- Direct Marketing DI
- 03701602300211 EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Pop Universal by Innovative Orthopedic Technologies IOT AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 037016023DT008PURISTAK | Class I | Active |
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Manufacturer
- Manufacturer
- Innovative Orthopedic Technologies IOT AG
- EUDAMED SRN
- CH-MF-000041418
- Authorised Representative
- Blue Broccoli GmbH LI-AR-000000233
Sources (1)
- EUDAMED f84abb3b-201a-445a-a694-f1a9a54621f4 61 fields · synced Jul 18, 2026