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GoFit Walker
EUDAMEDClass I (EU MDR)
Ref 635302(17L/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 635302(11XL/UNI/Gray&Silver)Ref 635302(17M/UNI/Gray&Silver)Ref 635302(11XS/UNI/Black)Ref 635302(11S/UNI/Gray&Silver)Ref 635302(17S/UNI/Gray&Silver)Ref 635302(11M/UNI/Black)Ref 635302(11M/UNI/Gray&Silver)Ref 635302(17XL/UNI/Black)Ref 635302(17M/UNI/Black)Ref 635302(17XS/UNI/Black)Ref 635302(11XL/UNI/Black)Ref 635302(11S/UNI/Black)Ref 635302(17S/UNI/Black)
Identity
- Trade Name
- GoFit Walker 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 EUDAMED635302(17L/UNI/Gray&Silver) EUDAMED635302(11XL/UNI/Gray&Silver) EUDAMED635302(17M/UNI/Gray&Silver) EUDAMED635302(11XS/UNI/Black) EUDAMED635302(11S/UNI/Gray&Silver) EUDAMED635302(17S/UNI/Gray&Silver) EUDAMED635302(11M/UNI/Black) EUDAMED635302(11M/UNI/Gray&Silver) EUDAMED635302(17XL/UNI/Black) EUDAMED635302(17M/UNI/Black) EUDAMED635302(17XS/UNI/Black) EUDAMED635302(11XL/UNI/Black) EUDAMED635302(11S/UNI/Black) EUDAMED635302(17S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964465805 EUDAMED04719964465829 EUDAMED04719964465768 EUDAMED04719964465676 EUDAMED04719964465706 EUDAMED04719964465720 EUDAMED04719964465737 EUDAMED04719964465744 EUDAMED04719964462088 EUDAMED04719964462064 EUDAMED04719964465683 EUDAMED04719964465812 EUDAMED04719964465690 EUDAMED04719964462057 EUDAMED
- Basic UDI-DI
- 47199644663WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
GoFit Walker 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (14)
- EUDAMED 97af8383-94c9-4973-ac20-745f1f748983 61 fields · synced Oct 6, 2026
- EUDAMED ee72fbb2-4cf2-4054-8882-3f87552b9b03 61 fields · synced May 11, 2026
- EUDAMED 21b61d0d-d400-432c-8222-b9a008c5e612 61 fields · synced May 16, 2026
- EUDAMED f5444208-144b-4e2e-be03-c4ae5f4b27b9 61 fields · synced May 16, 2026
- EUDAMED 692464b5-98ed-4df2-b676-b7f606fad65c 61 fields · synced May 16, 2026
- EUDAMED 58048090-4de1-4716-bda2-cf4d118c5cd6 61 fields · synced May 17, 2026
- EUDAMED 8c4e4a9a-5e2f-4593-aece-7779c5079029 61 fields · synced May 17, 2026
- EUDAMED 4480351e-bd09-4db8-8fea-f6cd754e2181 61 fields · synced May 17, 2026
- EUDAMED 33f5452f-c7e6-4205-ae14-5c9805175186 61 fields · synced May 17, 2026
- EUDAMED 9e74a357-9fc6-4568-a9cd-ffb914a644c6 61 fields · synced May 19, 2026
- EUDAMED 41fd57ed-9ff0-4999-a944-2f1f3102bf2b 61 fields · synced May 19, 2026
- EUDAMED 5bf0dfc3-217e-4809-aec3-49dd91df38a3 61 fields · synced May 19, 2026
- EUDAMED c7420808-d7bb-47a3-9882-75096abe937a 61 fields · synced May 19, 2026
- EUDAMED cb0f6901-d1a4-4f58-a4bc-e32c6dce33cf 61 fields · synced May 19, 2026