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Heel Pad 42-44
EUDAMEDClass I (EU MDR)
Ref Heel Pad 42-44Model Silicone Foot Orthotic Devices (Footcare)
by Pletra Ltd.
Identity
- Model / Reference
- Silicone Foot Orthotic Devices (Footcare) EUDAMEDHeel Pad 42-44 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779043811961 EUDAMED
- Basic UDI-DI
- 477904381FOOTCAREDV EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
Heel Pad 42-44 by Pletra Ltd. — 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 | 477904381FOOTCAREDV | Class I | Active |
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Manufacturer
- Manufacturer
- Pletra Ltd.
- EUDAMED SRN
- LT-MF-000004741
Sources (1)
- EUDAMED 7e354b58-bb0b-4c12-8515-8349104cc82d 61 fields · synced Oct 6, 2026