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Powerstep
EUDAMEDClass I (EU MDR)
Ref POW038Model Orthotics Ref POW068Ref POW198Ref POW066Ref POW074Ref POW088Ref POW151Ref POW157Ref POW082Ref POW200Ref POW172Ref POW004Ref POW035Ref POW204Ref POW056Ref POW059Ref POW057Ref POW054Ref POW083Ref POW024Ref POW133Ref POW008Ref POW070Ref POW156Ref POW179Ref POW144Ref POW190Ref POW005Ref POW195Ref POW063Ref POW106Ref POW199Ref POW058Ref POW031Ref POW173Ref POW192Ref POW170Ref POW085Ref POW006Ref POW140Ref POW077Ref POW007Ref POW174Ref POW023Ref POW147Ref POW177Ref POW053Ref POW062Ref POW032Ref POW124Ref POW158
Identity
- Trade Name
- Powerstep EUDAMED
- Device Name
- Orthotics EUDAMED
- Model / Reference
- Orthotics EUDAMEDPOW038 EUDAMEDPOW068 EUDAMEDPOW198 EUDAMEDPOW066 EUDAMEDPOW074 EUDAMEDPOW088 EUDAMEDPOW151 EUDAMEDPOW157 EUDAMEDPOW082 EUDAMEDPOW200 EUDAMEDPOW172 EUDAMEDPOW004 EUDAMEDPOW035 EUDAMEDPOW204 EUDAMEDPOW056 EUDAMEDPOW059 EUDAMEDPOW057 EUDAMEDPOW054 EUDAMEDPOW083 EUDAMEDPOW024 EUDAMEDPOW133 EUDAMEDPOW008 EUDAMEDPOW070 EUDAMEDPOW156 EUDAMEDPOW179 EUDAMEDPOW144 EUDAMEDPOW190 EUDAMEDPOW005 EUDAMEDPOW195 EUDAMEDPOW063 EUDAMEDPOW106 EUDAMEDPOW199 EUDAMEDPOW058 EUDAMEDPOW031 EUDAMEDPOW173 EUDAMEDPOW192 EUDAMEDPOW170 EUDAMEDPOW085 EUDAMEDPOW006 EUDAMEDPOW140 EUDAMEDPOW077 EUDAMEDPOW007 EUDAMEDPOW174 EUDAMEDPOW023 EUDAMEDPOW147 EUDAMEDPOW177 EUDAMEDPOW053 EUDAMEDPOW062 EUDAMEDPOW032 EUDAMEDPOW124 EUDAMEDPOW158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50126542051494 EUDAMED50126542061912 EUDAMED50126542071508 EUDAMED50126542061776 EUDAMED50126542057984 EUDAMED50126542052552 EUDAMED50126542062902 EUDAMED50126542063510 EUDAMED50126542051944 EUDAMED50126542071744 EUDAMED50126542069864 EUDAMED50126542058806 EUDAMED50126542051258 EUDAMED50126542072116 EUDAMED50126542021176 EUDAMED50126542021480 EUDAMED50126542021244 EUDAMED50126542020940 EUDAMED50126542052002 EUDAMED50126542050336 EUDAMED50126542059728 EUDAMED50126542059278 EUDAMED50126542062148 EUDAMED50126542063442 EUDAMED50126542070518 EUDAMED50126542053856 EUDAMED50126542070754 EUDAMED50126542058974 EUDAMED50126542071294 EUDAMED50126542061462 EUDAMED50126542060472 EUDAMED50126542071676 EUDAMED50126542021312 EUDAMED50126542050718 EUDAMED50126542069932 EUDAMED50126542070990 EUDAMED50126542069628 EUDAMED50126542052248 EUDAMED50126542059032 EUDAMED50126542053474 EUDAMED50126542058288 EUDAMED50126542059100 EUDAMED50126542070068 EUDAMED50126542050268 EUDAMED50126542054150 EUDAMED50126542070372 EUDAMED50126542020872 EUDAMED50126542061394 EUDAMED50126542050886 EUDAMED50126542053238 EUDAMED50126542063688 EUDAMED
- Basic UDI-DI
- 5012654ORT100M2 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
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
Powerstep by Cuxson Gerrard & Co. Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5012654ORT100M2 | Class I | Active |
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Manufacturer
- Manufacturer
- Cuxson Gerrard & Co. Ltd
- EUDAMED SRN
- GB-MF-000004499
- Authorised Representative
- Cuxson Gerrard Healthcare Ltd IE-AR-000003838
Sources (51)
- EUDAMED 26f25aa5-3f64-42df-bff1-a05e54194b3f 61 fields · synced Oct 5, 2026
- EUDAMED 641e2388-510e-4929-b0dc-908877e3e18c 61 fields · synced May 11, 2026
- EUDAMED ce8f0c14-14e2-481b-8378-4d9ecdc5e48a 61 fields · synced May 11, 2026
- EUDAMED 1a84c5db-220c-46d9-bc37-f8b332b08ff4 61 fields · synced May 11, 2026
- EUDAMED 1a85e66f-2fe5-40a5-8348-7b14d790ae2b 61 fields · synced May 11, 2026
- EUDAMED 16740685-5575-4a62-bb7c-afaa478a1ad1 61 fields · synced May 11, 2026
- EUDAMED 8b067eda-6e3b-4079-a5c3-d793305d1dd5 61 fields · synced May 16, 2026
- EUDAMED 6f42ea20-1fa6-48aa-b1e2-cf5b1bec8e10 61 fields · synced May 16, 2026
- EUDAMED b79603bf-64d7-4e4e-a1a9-7eb24063e2c6 61 fields · synced May 16, 2026
- EUDAMED eaa755ff-aa4a-4730-bcf9-f4d8be512eab 61 fields · synced May 16, 2026
- EUDAMED b1c70983-e50e-4589-bc37-ab8c1011cbee 61 fields · synced May 16, 2026
- EUDAMED 8db94d96-20aa-499c-85d0-2bf51daf756f 61 fields · synced May 17, 2026
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- EUDAMED cfe5f129-611b-478a-add2-f2ad3faefe83 61 fields · synced May 17, 2026
- EUDAMED 8c249896-6eaa-4241-8921-5f78c90b462d 61 fields · synced May 17, 2026
- EUDAMED c9b00dcf-7dc9-41ea-8b9f-836ee7d72b26 61 fields · synced May 17, 2026
- EUDAMED 8440dadd-9c49-49cf-be6c-70118db2380b 61 fields · synced May 17, 2026
- EUDAMED 35dd1ceb-99a6-4bc6-8f8c-ecb66f0af082 61 fields · synced May 17, 2026
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- EUDAMED 2df825dc-2999-4472-8d12-27babebd2794 61 fields · synced May 17, 2026
- EUDAMED 6626b5a4-d5c6-44ad-bc10-7faf3703929e 61 fields · synced May 17, 2026
- EUDAMED ed3f80c1-0c32-4bfa-9160-09ea89e0b9a9 61 fields · synced May 17, 2026
- EUDAMED 44ecdf7d-f3b9-416f-b39c-cbf4bf810acf 61 fields · synced May 17, 2026
- EUDAMED 77bca75d-7b25-4999-9920-d707bc58443f 61 fields · synced May 17, 2026
- EUDAMED 7c4af7e7-4b7b-4728-a4bd-df59cd74def0 61 fields · synced May 18, 2026
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- EUDAMED 619d4c32-2e4b-467b-bfb1-b9894a418609 61 fields · synced May 18, 2026
- EUDAMED dd66d823-6b47-47b1-9350-e4ce765c0b9f 61 fields · synced May 18, 2026
- EUDAMED ff220816-0b5b-4225-9083-be7e3cfbd02e 61 fields · synced May 18, 2026
- EUDAMED 78c1ba34-a1fe-45ec-9a30-6489c2d506c8 61 fields · synced May 18, 2026
- EUDAMED 1cb187c2-3950-43be-a2a0-7b352847773d 61 fields · synced May 18, 2026
- EUDAMED a505350d-cf20-4e1a-afdc-cee3bf8203e6 61 fields · synced May 18, 2026
- EUDAMED dd1fb7cc-b8e3-480c-9c86-13d5eb6fb3bc 61 fields · synced May 18, 2026
- EUDAMED 10e6c55b-5357-49cc-9e23-60c2d569cb99 61 fields · synced May 18, 2026
- EUDAMED 31b584b3-49fa-4176-b99d-95a320431cb4 61 fields · synced May 18, 2026
- EUDAMED 4bb91fa7-d339-4f02-89eb-c70a62be684d 61 fields · synced May 18, 2026
- EUDAMED 50a12336-a495-4793-b213-6e7b7a9f3600 61 fields · synced May 18, 2026
- EUDAMED 153aa9f4-57b3-4eaa-b64a-435d9d77adec 61 fields · synced May 18, 2026
- EUDAMED 076974c3-9da6-48bd-9e03-6c856de00283 61 fields · synced May 18, 2026
- EUDAMED eb12615c-d471-4d93-bca7-fc55cbb29b4f 61 fields · synced May 18, 2026