← Back to catalogue
ROM Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635201(14S/UNI/Black)Model Walking Boot:635101 Air Walking Boot:635102 Super Air Walking Boot:635103 Super Walking Boot:635104 ROM Walking Boot:635201 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 etcRef 635201(17L/UNI/Gray&Silver)Ref 635201(M/UNI/Gray&Silver)Ref 635201(14L/UNI/Black)Ref 635201(17XS/UNI/Black)Ref 635201(14XL/UNI/Black)Ref 635201(17XL/UNI/Black)
Identity
- Trade Name
- ROM Walking Boot EUDAMED
- Device Name
- Walking Boots (Ankle/foot orthosis) EUDAMED
- Model / Reference
- Walking Boot:635101 Air Walking Boot:635102 Super Air Walking Boot:635103 Super Walking Boot:635104 ROM Walking Boot:635201 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 etc EUDAMED635201(14S/UNI/Black) EUDAMED635201(17L/UNI/Gray&Silver) EUDAMED635201(M/UNI/Gray&Silver) EUDAMED635201(14L/UNI/Black) EUDAMED635201(17XS/UNI/Black) EUDAMED635201(14XL/UNI/Black) EUDAMED635201(17XL/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892939836 EUDAMED04719964465508 EUDAMED04719964465485 EUDAMED04719892939898 EUDAMED04719964468493 EUDAMED04719892939843 EUDAMED04719892939881 EUDAMED
- Basic UDI-DI
- 47199644663WN 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 Orthotech 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 | 47199644663WN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED 477a5467-1e86-45c4-9988-41490fdd31c6 61 fields · synced Oct 6, 2026
- EUDAMED 07c1062f-fc8a-4981-a804-50ea312b321a 61 fields · synced May 17, 2026
- EUDAMED a07ca99b-9475-49e5-a63d-70cc1ed1318b 61 fields · synced May 17, 2026
- EUDAMED 21d6145f-1c37-450d-b2b2-d37a27313805 61 fields · synced May 17, 2026
- EUDAMED 4f8989f2-2032-492c-a814-109fb1212bb6 61 fields · synced May 17, 2026
- EUDAMED 3504461b-cf0e-4705-becb-d03f001aa8d4 61 fields · synced May 18, 2026
- EUDAMED f218c755-648b-4c29-96ee-c002a1149418 61 fields · synced May 19, 2026