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Silicone Insoles
EUDAMEDClass I (EU MDR)
Ref 323-BRef 321-ARef 321-BRef 321-CRef 323-ERef 323-ARef 323-C
Identity
- Trade Name
- Silicone Insoles EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 323-B EUDAMED321-A EUDAMED321-B EUDAMED321-C EUDAMED323-E EUDAMED323-A EUDAMED323-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269508776 EUDAMED00840269508684 EUDAMED00840269508691 EUDAMED00840269508707 EUDAMED00840269508806 EUDAMED00840269508769 EUDAMED00840269508783 EUDAMED
- Basic UDI-DI
- 08402695CL1068N EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Silicone Insoles by La Pointique Int´l 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 | 08402695CL1068N | Class I | Active |
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Manufacturer
- Manufacturer
- La Pointique Int´l Ltd.
- EUDAMED SRN
- US-MF-000005204
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (7)
- EUDAMED dab27d18-e11b-4447-b73f-5b14655c8d91 61 fields · synced Aug 2, 2026
- EUDAMED 27d0fa39-017d-4f7f-a7e4-1d9f42e89130 61 fields · synced May 16, 2026
- EUDAMED 6a472ea7-56c2-4383-be3c-416fff085c6e 61 fields · synced May 16, 2026
- EUDAMED a065b75e-3fe6-47f4-be09-5062c68affbd 61 fields · synced May 17, 2026
- EUDAMED 6b924a66-fe31-4f89-b5c8-2caea13a673e 61 fields · synced May 17, 2026
- EUDAMED ff7ce2ba-bdaa-41e7-8d34-861829a3e9f8 61 fields · synced May 18, 2026
- EUDAMED 29a76500-16d9-4a85-853e-f8e7a36f2c9e 61 fields · synced May 18, 2026