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Boots
EUDAMEDClass I (EU MDR)
Ref BOO550Ref BOO586Model Orthotics Ref BOO565Ref BOO627Ref BOO576Ref BOO290Ref BOO581Ref BOO786Ref BOO757Ref BOO607Ref BOO848Ref BOO375Ref BOO295Ref BOO550/551
Identity
- Trade Name
- Boots EUDAMED
- Device Name
- Adhesive & Non-Adhesive Paddings & Strappings EUDAMEDOrthotics EUDAMEDPlantar Fasciitis Sock/Sleeve /Sock EUDAMED
- Model / Reference
- BOO550 EUDAMEDOrthotics EUDAMEDBOO586 EUDAMEDBOO565 EUDAMEDBOO627 EUDAMEDBOO576 EUDAMEDBOO290 EUDAMEDBOO581 EUDAMEDBOO786 EUDAMEDBOO757 EUDAMEDBOO607 EUDAMEDBOO848 EUDAMEDBOO375 EUDAMEDBOO295 EUDAMEDBOO550/551 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05045099273350 EUDAMED05045099238700 EUDAMED05045097807793 EUDAMED05045095025175 EUDAMED05045099251105 EUDAMED05045099177818 EUDAMED05045099238717 EUDAMED05045094811274 EUDAMED05045093673040 EUDAMED05045095025205 EUDAMED05045094182442 EUDAMED05045097811585 EUDAMED05045099177825 EUDAMED
- Basic UDI-DI
- 5012654PAD100C4 EUDAMED5012654ORT100M2 EUDAMED5012654SCK100FJ EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMEDM010203 PADDING FELT EUDAMEDM040799 SPECIAL PADS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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
Boots by Cuxson Gerrard & Co. 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 | 5012654PAD100C4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cuxson Gerrard & Co. Ltd
- EUDAMED SRN
- GB-MF-000004499
- Authorised Representative
- Cuxson Gerrard Healthcare Ltd IE-AR-000003838
Sources (14)
- EUDAMED 3108f3ac-6d55-4b19-ba5f-60d858e378ba 61 fields · synced Oct 6, 2026
- EUDAMED 8045b0de-13a4-49a8-a823-cbdd663ece49 61 fields · synced May 16, 2026
- EUDAMED 4e257cc1-ac73-450a-adb2-b45dbf4f2c6d 61 fields · synced May 17, 2026
- EUDAMED 762d36db-bee5-4333-b297-4dd40d3b06f5 61 fields · synced May 17, 2026
- EUDAMED 247d95df-25b5-47ef-8352-ad3620939d16 61 fields · synced May 17, 2026
- EUDAMED 4baf15d9-7968-41bf-8cc4-68943f030d45 61 fields · synced May 17, 2026
- EUDAMED 24724947-6d12-4e62-b66a-24fb46dd4a54 61 fields · synced May 17, 2026
- EUDAMED 60a575e5-9f50-4e02-9a12-a84bfc32948e 61 fields · synced May 17, 2026
- EUDAMED 7052a609-6e50-46ee-8fd0-7edfc06d74f3 61 fields · synced May 17, 2026
- EUDAMED c910a459-1923-4ac2-9564-c3fc3b798bc1 61 fields · synced May 18, 2026
- EUDAMED 28b91b41-4cd3-4c98-bcac-c7e78ceea275 61 fields · synced May 19, 2026
- EUDAMED 596cf6bf-23af-4b2e-8fc8-01900f1ed88a 61 fields · synced May 19, 2026
- EUDAMED 155e7358-1921-4d5e-94e1-c10da4cb7293 61 fields · synced May 19, 2026
- EUDAMED 3465203c-90e2-4b83-ab12-4026f444b18c 61 fields · synced Aug 1, 2026