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Polygel All-purpose Insoles
EUDAMEDClass I (EU MDR)
Ref 304-11Ref 304-9Ref 304-10Ref 304-5Ref 304-7Ref 304-8Ref 304-6
Identity
- Trade Name
- Polygel All-purpose Insoles EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 304-11 EUDAMED304-9 EUDAMED304-10 EUDAMED304-5 EUDAMED304-7 EUDAMED304-8 EUDAMED304-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269508066 EUDAMED00840269508042 EUDAMED00840269508059 EUDAMED00840269508004 EUDAMED00840269508028 EUDAMED00840269508035 EUDAMED00840269508011 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
Polygel All-purpose Insoles by La Pointique Int´l 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 | 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 1914fe8b-4242-45b0-9be8-52caae4107b6 61 fields · synced Sep 18, 2026
- EUDAMED 082171fe-39b8-4a6b-b93a-ceb1c985e7f8 61 fields · synced May 17, 2026
- EUDAMED 55592ee6-205e-476f-b1fd-4fca405c5737 61 fields · synced May 18, 2026
- EUDAMED 18e06c02-3d81-4bb7-86d2-967bcd73a4aa 61 fields · synced May 18, 2026
- EUDAMED 7d65c712-ec38-4f54-bad9-624a5d7ad9c8 61 fields · synced May 18, 2026
- EUDAMED 1dd1c486-d761-4468-b8d1-b4953258f43a 61 fields · synced May 19, 2026
- EUDAMED 7deac1ae-ecb5-430d-b8d6-5cf69ca00f24 61 fields · synced May 19, 2026