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Insoles
EUDAMEDClass I (EU MDR)
Ref UP4567MRef UP4568SRef UP4534LRef UP4568LRef UP4567XRef UP4569XRef UP4567LRef UP4569XSRef UP4510SRef UP4575MRef UP4570XRef UP4571XRef UP4569SRef UP4565S
Identity
- Device Name
- Insoles EUDAMED
- Model / Reference
- UP4567M EUDAMEDUP4568S EUDAMEDUP4534L EUDAMEDUP4568L EUDAMEDUP4567X EUDAMEDUP4569X EUDAMEDUP4567L EUDAMEDUP4569XS EUDAMEDUP4510S EUDAMEDUP4575M EUDAMEDUP4570X EUDAMEDUP4571X EUDAMEDUP4569S EUDAMEDUP4565S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060242688232 EUDAMED05060242687679 EUDAMED05060242686306 EUDAMED05060242687693 EUDAMED05060242688256 EUDAMED05060242687532 EUDAMED05060242688249 EUDAMED05060242687495 EUDAMED05060242686276 EUDAMED05060242688393 EUDAMED05060242687754 EUDAMED05060242688300 EUDAMED05060242687501 EUDAMED05060242686436 EUDAMED
- Basic UDI-DI
- 50602426845JZ EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Insoles by Burton McCall 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 | 50602426845JZ | Class I | Active |
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Manufacturer
- Manufacturer
- Burton McCall Ltd
- EUDAMED SRN
- UK-MF-000051789
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (14)
- EUDAMED 43dd6201-c78f-4185-b5c6-b375b4987347 61 fields · synced Sep 17, 2026
- EUDAMED acce1d27-d8e7-49ac-82a6-3fb395766e19 61 fields · synced May 17, 2026
- EUDAMED 34116886-d082-4d91-bcc3-ba26f6cde0b8 61 fields · synced May 17, 2026
- EUDAMED 7c47d41f-f9dd-4ebb-ae31-2aeb1eeb4a7f 61 fields · synced May 17, 2026
- EUDAMED f87a67f9-8695-42f9-8e83-30c2da7e29cb 61 fields · synced May 18, 2026
- EUDAMED c1ec63d9-0d4b-4849-ac68-6358e4b0f060 61 fields · synced May 18, 2026
- EUDAMED 42291b2d-8480-4813-9bec-f869f7b2ab14 61 fields · synced May 18, 2026
- EUDAMED 17b5ae5b-7b0e-49b6-86ed-09810a36df7c 61 fields · synced May 18, 2026
- EUDAMED 1ab5c441-e0cd-4725-a275-f2aec314b064 61 fields · synced May 18, 2026
- EUDAMED be1d9312-56b8-4d18-8fa2-647d76ac0430 61 fields · synced May 18, 2026
- EUDAMED dbe9c61d-af92-437a-add8-593bd3d00e60 61 fields · synced May 18, 2026
- EUDAMED de59a9a6-7db3-4f2a-9953-63fc76fb9816 61 fields · synced May 18, 2026
- EUDAMED b4231e78-c8fe-46bb-9fa2-a40ba45d664d 61 fields · synced May 19, 2026
- EUDAMED b33ffc19-9adb-46ed-96ec-d098b650e022 61 fields · synced May 19, 2026