Identity
- Trade Name
- POLO EUDAMED
- Device Name
- MEMO Obuwie diagnostyczno-korekcyjne EUDAMED
- Model / Reference
- DRMB4C3AB132A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901780401368 EUDAMED
- Basic UDI-DI
- 59017804DRMDQG EUDAMED
- Direct Marketing DI
- 05901780401368 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
Polo by mdh sp. z o. o. — 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 | 59017804DRMDQG | Class I | Active |
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Manufacturer
- Manufacturer
- mdh sp. z o. o.
- EUDAMED SRN
- PL-MF-000011406
Sources (1)
- EUDAMED 3b52ef0a-4c6b-4821-b15d-a0e96e5f7a57 61 fields · synced Sep 30, 2026