Identity
- Trade Name
- iORTO Professional EUDAMED
- Device Name
- iORTO Professional EUDAMED
- Model / Reference
- TOTAL SUPPORT (STANDARD) IPM75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902574208293 EUDAMED
- Basic UDI-DI
- 59025742IORTO-PROSW EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
iORTO Professional by Zbigniew Frąckowiak Mazbit Przedsiębiorstwo — 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 | 59025742IORTO-PROSW | Class I | Active |
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Manufacturer
- Manufacturer
- Zbigniew Frąckowiak Mazbit Przedsiębiorstwo
- EUDAMED SRN
- PL-MF-000039173
Sources (1)
- EUDAMED 3e9ce5dd-92ac-4a3e-a891-cfd77bdefb9f 61 fields · synced Oct 6, 2026