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U-Profile Orthotic Insoles
EUDAMEDClass I (EU MDR)
Ref 309-XSRef 309-SRef 309-LRef 309-M
Identity
- Trade Name
- U-Profile Orthotic Insoles EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 309-XS EUDAMED309-S EUDAMED309-L EUDAMED309-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269508394 EUDAMED00840269508400 EUDAMED00840269508424 EUDAMED00840269508417 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
U-Profile Orthotic 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 (4)
- EUDAMED a13cbcea-e3f8-411b-b526-a5e321b76c34 61 fields · synced Aug 4, 2026
- EUDAMED a70c3afa-bf4e-4ccd-9506-357f00e1a99f 61 fields · synced May 16, 2026
- EUDAMED 605cbaa7-a0ca-467e-baa7-3ac79aaaec97 61 fields · synced May 16, 2026
- EUDAMED cca2362b-d732-4951-a195-332aed9b0674 61 fields · synced May 18, 2026