Identity
- Trade Name
- PURIST / OLH - Boot S EUDAMED
- Device Name
- PURIST Leg Positioning System EUDAMED
- Model / Reference
- 6883360 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701602300402 EUDAMED
- Basic UDI-DI
- 037016023DT008PURISTAK EUDAMED
- Direct Marketing DI
- 03701602300402 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
PURIST / OLH - Boot S 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Innovative Orthopedic Technologies IOT AG
- EUDAMED SRN
- CH-MF-000041418
- Authorised Representative
- Blue Broccoli GmbH LI-AR-000000233
Sources (1)
- EUDAMED 72971cfc-f389-49ef-b0b7-d94cc8f5f948 61 fields · synced Jul 20, 2026