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Performance Insoles
EUDAMEDClass I (EU MDR)
Ref 303-6Ref 303-11Ref 303-10Ref 303-7Ref 303-8Ref 303-9
Identity
- Trade Name
- Performance Insoles EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 303-6 EUDAMED303-11 EUDAMED303-10 EUDAMED303-7 EUDAMED303-8 EUDAMED303-9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269507946 EUDAMED00840269507991 EUDAMED00840269507984 EUDAMED00840269507953 EUDAMED00840269507960 EUDAMED00840269507977 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
Performance 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 (6)
- EUDAMED 255f6e1e-d3c7-42f0-ac9e-3a5d64d202fd 61 fields · synced Aug 2, 2026
- EUDAMED 7bfe0f1a-c781-42fa-93d9-4fc587ba5d46 61 fields · synced May 17, 2026
- EUDAMED e7dde0ee-8f52-4f29-ae80-df672655fb89 61 fields · synced May 18, 2026
- EUDAMED 5bfe3a29-7ba5-4dfd-b0a2-b160770a5394 61 fields · synced May 18, 2026
- EUDAMED 459e9b29-d0f3-4792-9819-67641194b896 61 fields · synced May 18, 2026
- EUDAMED 9d25481c-538e-4ec8-b8e6-e0606cc9376c 61 fields · synced May 18, 2026