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Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635101(11S/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 635101(17L/UNI/Gray&Silver)Ref 635101(17XS/UNI/Gray&Silver)Ref 635101(11S/UNI/Gray&Silver)Ref 635101(17S/UNI/Black)Ref 635101(17XL/UNI/Black)Ref 635101(17S/UNI/Gray&Silver)
Identity
- Trade Name
- Walking Boot 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 EUDAMED635101(11S/UNI/Black) EUDAMED635101(17L/UNI/Gray&Silver) EUDAMED635101(17XS/UNI/Gray&Silver) EUDAMED635101(11S/UNI/Gray&Silver) EUDAMED635101(17S/UNI/Black) EUDAMED635101(17XL/UNI/Black) EUDAMED635101(17S/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892931007 EUDAMED04719872864783 EUDAMED04719872864820 EUDAMED04719872864752 EUDAMED04719892931014 EUDAMED04719892931076 EUDAMED04719872864806 EUDAMED
- Basic UDI-DI
- 47198728663WQ EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Walking Boot by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 47198728663WQ | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED 6b64e715-472d-46a5-8977-de34356842dd 61 fields · synced Oct 5, 2026
- EUDAMED 79cbd206-951f-4b29-85d9-be4d70eff219 61 fields · synced May 16, 2026
- EUDAMED 2222c5b3-7679-48d9-bbbf-5464df692451 61 fields · synced May 17, 2026
- EUDAMED 713222be-3e15-4636-9038-25df6b96b366 61 fields · synced May 17, 2026
- EUDAMED 00b1d0d6-ca9b-49b9-9150-0c5642e549f3 61 fields · synced May 18, 2026
- EUDAMED 0c33f399-25b8-4e07-9bd2-2999889c1d21 61 fields · synced May 19, 2026
- EUDAMED f0dbc1f9-e3d3-4ab9-b831-2084e3f8f738 61 fields · synced May 19, 2026