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Lite Ped.Walking Boot
EUDAMEDClass I (EU MDR)
Ref 638801(XL/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 638801(M/UNI/Black)Ref 638801(S/UNI/Gray&Silver)Ref 638801(L/UNI/Black)
Identity
- Trade Name
- Lite Ped.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 EUDAMED638801(XL/UNI/Black) EUDAMED638801(M/UNI/Black) EUDAMED638801(S/UNI/Gray&Silver) EUDAMED638801(L/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892933377 EUDAMED04719892933353 EUDAMED04719892931502 EUDAMED04719892933360 EUDAMED
- Basic UDI-DI
- 47198728663WQ EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Lite Ped.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 (4)
- EUDAMED 0299c412-af2b-4691-955e-d84ad5c616a8 61 fields · synced Oct 6, 2026
- EUDAMED 9261d760-3418-475f-ac4f-99ced199083a 61 fields · synced May 16, 2026
- EUDAMED 74bf6745-fe7b-4d0f-9483-3e78d05e3211 61 fields · synced May 18, 2026
- EUDAMED fc200322-a1ff-4be5-b735-577bc9c20271 61 fields · synced May 19, 2026