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Fixed Walker
EUDAMEDClass I (EU MDR)
Ref WK001-BModel "WK001 17"" Tall Pneumatic Walker WK001-B 17"" Tall Pneumatic Walker WK001-C 17"" Tall Pneumatic Walker WK002 11"" Short Pneumatic Walker WK002-B 11"" etcRef WK002-B
Identity
- Device Name
- Fixed Walker EUDAMED
- Model / Reference
- "WK001 17"" Tall Pneumatic Walker WK001-B 17"" Tall Pneumatic Walker WK001-C 17"" Tall Pneumatic Walker WK002 11"" Short Pneumatic Walker WK002-B 11"" etc EUDAMEDWK001-B EUDAMEDWK002-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761008 EUDAMED06975816761015 EUDAMED
- Basic UDI-DI
- 697581676FixedWalker5J EUDAMED
- EMDN Code
- Y090618 LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Fixed Walker by Xiamen Huakang Orthopedic Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697581676FixedWalker5J | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 14301808-cd54-4eaa-bd73-5c4bbb6e274f 61 fields · synced Oct 6, 2026
- EUDAMED 4db10ca2-391f-4128-8adc-b7bd7ac90241 61 fields · synced May 17, 2026