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Ankle Support
EUDAMEDClass I (EU MDR)
Ref H02BModel ADK,CAS4,CAS5,CAS6,CAS7,CAS8,AS10,AS11,AS12,AS13,AS14,AS15,AS16,AS17,AS18,AS19,AS20,AS21,AS22,AS23,AS24,AS25,AS26,AS27,AS28,AS29,AS30,AS31,AS32,AS33,AS34,AS35,AS36,AS37,AS38,AS39,AS40,AS41,AS42,AS43,AS44,AS45,AS46,etc
Identity
- Device Name
- Ankle Support EUDAMED
- Model / Reference
- ADK,CAS4,CAS5,CAS6,CAS7,CAS8,AS10,AS11,AS12,AS13,AS14,AS15,AS16,AS17,AS18,AS19,AS20,AS21,AS22,AS23,AS24,AS25,AS26,AS27,AS28,AS29,AS30,AS31,AS32,AS33,AS34,AS35,AS36,AS37,AS38,AS39,AS40,AS41,AS42,AS43,AS44,AS45,AS46,etc EUDAMEDH02B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934530607795 EUDAMED
- Basic UDI-DI
- 69345306AnkleSupport38 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
Ankle Support by Yangzhou Jindu Sporting Goods 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 | 69345306AnkleSupport38 | Class I | Active |
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Manufacturer
- Manufacturer
- Yangzhou Jindu Sporting Goods Co., Ltd.
- EUDAMED SRN
- CN-MF-000041954
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8f382e51-3a32-4a1e-8497-8c0601d276a7 61 fields · synced Jun 18, 2026