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Power Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635301(11XL/UNI/Gray&Silver)Model Walking Boot:635101 Air Walking Boot:635102 Super Air Walking Boot:635103 Super Walking Boot:635104 ROM Walking Boot:635201 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 etcRef 635301(11S/UNI/Black)Ref 635101(17XS/UNI/Gray&Silver)Ref 635301(11L/UNI/Black)Ref 635101(17L/UNI/Gray&Silver)Ref 635301(17M/UNI/Gray&Silver)Ref 635104(17S/UNI/Black)Ref 635101(17XL/UNI/Black)Ref 635204(14XS/UNI/Black)Ref 635101(11S/UNI/Gray&Silver)Ref 635202(17S/UNI/Gray&Silver)Ref 635101(17XL/UNI/Gray&Silver)Ref 635102(17XL/UNI/Gray&Silver)Ref 635101(11L/UNI/Gray&Silver)Ref 635301(17S/UNI/Gray&Silver)Ref 635301(11L/UNI/Gray&Silver)Ref 635101(17S/UNI/Black)Ref 635301(11M/UNI/Black)Ref 635301(17L/UNI/Gray&Silver)Ref 635301(17S/UNI/Black)Ref 635101(17M/UNI/Gray&Silver)Ref 635101(11XS/UNI/Gray&Silver)Ref 635101(11XL/UNI/Gray&Silver)Ref 635101(17M/UNI/Black)Ref 635201(17S/UNI/Black)Ref 635301(17M/UNI/Black)
Identity
- Trade Name
- Power Walking Boot EUDAMEDWalking Boot EUDAMEDSuper Walking Boot EUDAMEDROM Air Walking Boot Pro EUDAMEDROM Air Walking Boot EUDAMEDAir Walking Boot EUDAMEDROM Walking Boot EUDAMED
- Device Name
- Walking Boots (Ankle/foot orthosis) EUDAMED
- Model / Reference
- Walking Boot:635101 Air Walking Boot:635102 Super Air Walking Boot:635103 Super Walking Boot:635104 ROM Walking Boot:635201 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 etc EUDAMED635301(11XL/UNI/Gray&Silver) EUDAMED635301(11S/UNI/Black) EUDAMED635101(17XS/UNI/Gray&Silver) EUDAMED635301(11L/UNI/Black) EUDAMED635101(17L/UNI/Gray&Silver) EUDAMED635301(17M/UNI/Gray&Silver) EUDAMED635104(17S/UNI/Black) EUDAMED635101(17XL/UNI/Black) EUDAMED635204(14XS/UNI/Black) EUDAMED635101(11S/UNI/Gray&Silver) EUDAMED635202(17S/UNI/Gray&Silver) EUDAMED635101(17XL/UNI/Gray&Silver) EUDAMED635102(17XL/UNI/Gray&Silver) EUDAMED635101(11L/UNI/Gray&Silver) EUDAMED635301(17S/UNI/Gray&Silver) EUDAMED635301(11L/UNI/Gray&Silver) EUDAMED635101(17S/UNI/Black) EUDAMED635301(11M/UNI/Black) EUDAMED635301(17L/UNI/Gray&Silver) EUDAMED635301(17S/UNI/Black) EUDAMED635101(17M/UNI/Gray&Silver) EUDAMED635101(11XS/UNI/Gray&Silver) EUDAMED635101(11XL/UNI/Gray&Silver) EUDAMED635101(17M/UNI/Black) EUDAMED635201(17S/UNI/Black) EUDAMED635301(17M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964465652 EUDAMED04719964465553 EUDAMED04719892939577 EUDAMED04719964465614 EUDAMED04719892939539 EUDAMED04719964465607 EUDAMED04719964461029 EUDAMED04719964465409 EUDAMED04719964468530 EUDAMED04719892939508 EUDAMED04719964460039 EUDAMED04719892939560 EUDAMED04719892939775 EUDAMED04719892939485 EUDAMED04719964465577 EUDAMED04719964465621 EUDAMED04719964465348 EUDAMED04719964465584 EUDAMED04719964465638 EUDAMED04719964460237 EUDAMED04719892939546 EUDAMED04719892939522 EUDAMED04719892939515 EUDAMED04719964465362 EUDAMED04719892939874 EUDAMED04719964460220 EUDAMED
- Basic UDI-DI
- 47199644663WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDGermany EUDAMEDRomania EUDAMEDNetherlands EUDAMEDGreece 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: Ankle/foot orthosis
Power Walking Boot by Orthotech Rehabilitation 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 | 47199644663WN | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (26)
- EUDAMED 6d8690c5-3659-47f8-af5a-0902bf2e1bab 61 fields · synced Sep 18, 2026
- EUDAMED a3ac4084-ef85-43e3-9f39-8bee0eebc936 61 fields · synced May 16, 2026
- EUDAMED fbdc87d1-1dae-49b6-997d-934ab41708b6 61 fields · synced May 16, 2026
- EUDAMED bb3aa5d0-2bae-4363-b7f5-7897cd4eb610 61 fields · synced May 16, 2026
- EUDAMED 97dc12eb-3f55-458b-b598-fcb518af13f2 61 fields · synced May 16, 2026
- EUDAMED f998aa2c-79ae-47b6-b427-dea9cc1b679c 61 fields · synced May 16, 2026
- EUDAMED d037ccc3-bf63-44c6-a395-f7a752924dd3 61 fields · synced May 17, 2026
- EUDAMED d657cebb-bf1d-4fae-aef1-55356496fe6e 61 fields · synced May 17, 2026
- EUDAMED 27c13b0b-d6a7-420b-982d-b2c3f9d5b8c2 61 fields · synced May 17, 2026
- EUDAMED 3dbd2d6d-35e5-4856-b6b9-ae3b5a364131 61 fields · synced May 17, 2026
- EUDAMED 0d8b862b-6877-4117-a2e4-fdfe178929f3 61 fields · synced May 17, 2026
- EUDAMED a25896c3-0d84-4ae0-9f70-a5eabe508608 61 fields · synced May 17, 2026
- EUDAMED 3409f363-d463-4b7f-b686-3638a143149e 61 fields · synced May 17, 2026
- EUDAMED 0da2f62d-6ff8-48e2-8757-a8bf0a05b651 61 fields · synced May 17, 2026
- EUDAMED 586f9c20-fab6-4934-acdd-5299400f3a8d 61 fields · synced May 17, 2026
- EUDAMED fb00c068-899d-42e4-92db-a64309404113 61 fields · synced May 18, 2026
- EUDAMED dfc9488c-8ba4-4af5-ab9d-f52af877dc65 61 fields · synced May 18, 2026
- EUDAMED 0c3bcde0-54f3-4338-85ce-cf3d6f5ab513 61 fields · synced May 19, 2026
- EUDAMED 03c390ef-640d-47d9-af1e-b678bfba486e 61 fields · synced May 19, 2026
- EUDAMED 58c18a6a-99fb-42ec-9733-349caeec9e73 61 fields · synced May 19, 2026
- EUDAMED 3c2ca98a-f8ae-4814-a5af-d9bbd23d030a 61 fields · synced May 19, 2026
- EUDAMED 2bbcf3cc-d55e-4780-8c69-507d3f7e6ab6 61 fields · synced May 19, 2026
- EUDAMED de3bdae0-6b58-4f09-ac5a-692ce4d432d7 61 fields · synced May 19, 2026
- EUDAMED 536d5f8a-7851-4288-b3a0-55342f7f78ac 61 fields · synced May 19, 2026
- EUDAMED 14b3f055-3e31-40dc-b0d8-6d27c8e428d3 61 fields · synced May 19, 2026
- EUDAMED eb5162cf-ee24-405f-9891-c0e44a4b4d5c 61 fields · synced May 19, 2026