Identity
- Trade Name
- VARVASTUPPI EUDAMED
- Device Name
- Ortesis Podológicas/Podiatry Orthoses EUDAMED
- Model / Reference
- MI227 S EUDAMEDMI227 L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048049592 EUDAMED08434048049585 EUDAMED
- Basic UDI-DI
- 843404825PRODUCTOSPIEV7 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Varvastuppi by Prim S.a. — 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 | 843404825PRODUCTOSPIEV7 | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED 7d5013e5-e184-4d88-b5f9-ec8c77545fd0 61 fields · synced Jul 10, 2026
- EUDAMED d25fb313-fabf-4b62-8e4f-ae6c44bf9bba 61 fields · synced May 19, 2026