Identity
- Trade Name
- iORTO Professional EUDAMED
- Device Name
- iORTO Professional EUDAMED
- Model / Reference
- RUN (NH-SPACE) IPS40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902574212962 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
Category: Orthotic insole, prefabricated, non-antimicrobial
iORTO Professional by Zbigniew Frąckowiak Mazbit Przedsiębiorstwo — Class I — 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 | 59025742IORTO-PROSW | Class I | Active |
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Manufacturer
- Manufacturer
- Zbigniew Frąckowiak Mazbit Przedsiębiorstwo
- EUDAMED SRN
- PL-MF-000039173
Sources (1)
- EUDAMED 6f169c76-3c22-471d-b006-96143664501a 61 fields · synced Jun 19, 2026