← Back to catalogue
GoFit Walker
EUDAMEDClass I (EU MDR)
Ref 635302(17L/UNI/Black)Model Air Walking Boot:635102 GoFit Walker:635302 Lite Ped.Walking Boot:638801 Power Walking Boot:635301 Pro Ped.Walking Boot:638802 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 ROM Walking Boot:635201 etcRef 635302(11M/UNI/Black)Ref 635302(17M/UNI/Black)Ref 635302(11M/UNI/Gray&Silver)Ref 635302(11L/UNI/Black)Ref 635302(11XL/UNI/Black)Ref 635302(17S/UNI/Black)Ref 635302(17S/UNI/Gray&Silver)Ref 635302(11XL/UNI/Gray&Silver)Ref 635302(17XL/UNI/Black)
Identity
- Trade Name
- GoFit Walker EUDAMED
- Device Name
- Walking Boots (Ankle/foot orthosis) EUDAMED
- Model / Reference
- Air Walking Boot:635102 GoFit Walker:635302 Lite Ped.Walking Boot:638801 Power Walking Boot:635301 Pro Ped.Walking Boot:638802 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 ROM Walking Boot:635201 etc EUDAMED635302(17L/UNI/Black) EUDAMED635302(11M/UNI/Black) EUDAMED635302(17M/UNI/Black) EUDAMED635302(11M/UNI/Gray&Silver) EUDAMED635302(11L/UNI/Black) EUDAMED635302(11XL/UNI/Black) EUDAMED635302(17S/UNI/Black) EUDAMED635302(17S/UNI/Gray&Silver) EUDAMED635302(11XL/UNI/Gray&Silver) EUDAMED635302(17XL/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872867463 EUDAMED04719892931403 EUDAMED04719872867456 EUDAMED04719892931410 EUDAMED04719892931441 EUDAMED04719892931489 EUDAMED04719872867449 EUDAMED04719892931397 EUDAMED04719892931496 EUDAMED04719872867470 EUDAMED
- Basic UDI-DI
- 47198728663WQ 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 Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 | 47198728663WQ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (10)
- EUDAMED 848780de-a010-47d0-a1da-4688ec1e0358 61 fields · synced Oct 7, 2026
- EUDAMED 9999cac9-003a-4db3-aefc-7f8c0e736b42 61 fields · synced May 16, 2026
- EUDAMED edca791d-2109-48b5-826f-0bce84df3e39 61 fields · synced May 17, 2026
- EUDAMED 3fa01170-a559-4b0e-8753-5b44229a5ab1 61 fields · synced May 17, 2026
- EUDAMED 0abba3cc-78ad-4e0a-92de-3dbb126c0e5e 61 fields · synced May 17, 2026
- EUDAMED ddd2ebc4-2b39-403e-9142-60ce57a29e78 61 fields · synced May 17, 2026
- EUDAMED c77f5822-37f3-4efe-8b44-a7d1a834a7ac 61 fields · synced May 18, 2026
- EUDAMED 8210f3cd-d483-4ba0-83a2-40f86b11aaa9 61 fields · synced May 18, 2026
- EUDAMED 2773f032-cd73-4705-baf3-b0817914a8ca 61 fields · synced May 19, 2026
- EUDAMED 2e2d9d81-48d9-4827-8bd6-adbde4c49dab 61 fields · synced May 19, 2026