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ROM Air Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635202(17XL/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 635202(14XS/UNI/Black)Ref 635202(14L/UNI/Gray&Silver)Ref 635202(17XL/UNI/Gray&Silver)Ref 635202(17M/UNI/Gray&Silver)Ref 635202(17M/UNI/Black)Ref 635202(17L/UNI/Gray&Silver)Ref 635202(17L/UNI/Black)Ref 635202(14XL/UNI/Gray&Silver)
Identity
- Trade Name
- ROM Air 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 EUDAMED635202(17XL/UNI/Black) EUDAMED635202(14XS/UNI/Black) EUDAMED635202(14L/UNI/Gray&Silver) EUDAMED635202(17XL/UNI/Gray&Silver) EUDAMED635202(17M/UNI/Gray&Silver) EUDAMED635202(17M/UNI/Black) EUDAMED635202(17L/UNI/Gray&Silver) EUDAMED635202(17L/UNI/Black) EUDAMED635202(14XL/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892931823 EUDAMED04719892934190 EUDAMED04719872865285 EUDAMED04719872865261 EUDAMED04719872865247 EUDAMED04719892931205 EUDAMED04719872865230 EUDAMED04719892931212 EUDAMED04719872865315 EUDAMED
- Basic UDI-DI
- 47198728663WQ EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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 Air 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 (9)
- EUDAMED 806e7eba-852d-4f56-ac26-e1cdc5058166 61 fields · synced Oct 6, 2026
- EUDAMED 828bc2c6-e46c-417c-8847-e5c2821cc019 61 fields · synced May 16, 2026
- EUDAMED f0ae0b05-72e1-4d2b-badb-3b1b7411ae07 61 fields · synced May 16, 2026
- EUDAMED 725af3b6-a471-45bf-b88b-fff020798f5b 61 fields · synced May 16, 2026
- EUDAMED 080e24c0-f5e1-43ab-8117-d18c9d657e5d 61 fields · synced May 16, 2026
- EUDAMED c09142bb-a891-4ad5-97ef-cfc9d657af02 61 fields · synced May 17, 2026
- EUDAMED 63d7a3f8-03f0-414d-8506-082c15417e95 61 fields · synced May 17, 2026
- EUDAMED fb211c48-a62b-4bcc-90c7-d5f3db6f2845 61 fields · synced May 17, 2026
- EUDAMED ece5de31-ad37-4831-a948-34a04cd03fb0 61 fields · synced May 19, 2026