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ROM Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635201(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 635201(14M/UNI/Black)Ref 635201(17XL/UNI/Black)Ref 635201(XL/UNI/Gray&Silver)Ref 635201(17S/UNI/Black)Ref 635201(17L/UNI/Gray&Silver)
Identity
- Trade Name
- ROM 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 EUDAMED635201(17L/UNI/Black) EUDAMED635201(14M/UNI/Black) EUDAMED635201(17XL/UNI/Black) EUDAMED635201(XL/UNI/Gray&Silver) EUDAMED635201(17S/UNI/Black) EUDAMED635201(17L/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872865100 EUDAMED04719872865070 EUDAMED04719872865131 EUDAMED04719892931182 EUDAMED04719872865124 EUDAMED04719892931175 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
ROM Walking Boot by Zhangpu Ortholife 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 | 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 (6)
- EUDAMED f4a3639f-c809-415b-8659-954842080e54 61 fields · synced Oct 6, 2026
- EUDAMED bd66ae92-b2d3-4492-8367-6f4195703f55 61 fields · synced May 16, 2026
- EUDAMED 5ff20ffb-d5f6-416b-9483-0ad35efc2317 61 fields · synced May 17, 2026
- EUDAMED 950216fd-56e3-455d-b22f-4f126b4f1268 61 fields · synced May 17, 2026
- EUDAMED 68601aef-c8cb-429d-b7b1-97c1a266fc9b 61 fields · synced May 17, 2026
- EUDAMED c4acc4f4-f204-49f0-8548-17f25ab2b6f6 61 fields · synced May 18, 2026