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Toe Spacer Flat
EUDAMEDClass I (EU MDR)
Ref Toe Spacer FlatModel Silicone Foot Orthotic Devices (Footcare)
by Pletra Ltd.
Identity
- Model / Reference
- Silicone Foot Orthotic Devices (Footcare) EUDAMEDToe Spacer Flat EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779043810315 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Toe Spacer Flat by Pletra Ltd. — 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 | 477904381FOOTCAREDV | Class I | Active |
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Manufacturer
- Manufacturer
- Pletra Ltd.
- EUDAMED SRN
- LT-MF-000004741
Sources (1)
- EUDAMED 9fc3e641-c306-4efd-9177-3cf225c337e2 61 fields · synced Jun 18, 2026