Identity
- Trade Name
- OLH - Denyer EUDAMEDOLH - Denyer Plus EUDAMED
- Device Name
- PURIST Leg Positioning System EUDAMED
- Model / Reference
- 6813040 EUDAMED6813049 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701602300310 EUDAMED03701602300303 EUDAMED
- Basic UDI-DI
- 037016023DT008PURISTAK EUDAMED
- Direct Marketing DI
- 03701602300310 EUDAMED03701602300303 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
OLH - Denyer 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 (2)
- EUDAMED b10acb38-4e76-4d0f-8a9f-261825651367 61 fields · synced Aug 2, 2026
- EUDAMED 9cc72f2b-470e-4612-973f-dfcc2b683846 61 fields · synced May 19, 2026