Identity
- Trade Name
- DIVARICATORE PRT-S13 EUDAMED
- Device Name
- ORTESI PER PIEDE (INCLUSI PLANTARI E INSERTI) - PIEDE EUDAMED
- Model / Reference
- PRT-S13V.S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033609575473 EUDAMED
- Basic UDI-DI
- 803348865Y06120301BT EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Divaricatore Prt-S13 by F.G.P. s.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 803348865Y06120301BT | Class I | Active |
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Manufacturer
- Manufacturer
- F.G.P. s.r.l.
- EUDAMED SRN
- IT-MF-000043862
Sources (1)
- EUDAMED ff100b81-f09c-48c4-9661-b17900b02829 61 fields · synced Jun 18, 2026