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Lower Limb Brace
EUDAMEDClass I (EU MDR)
Ref K101Model K101 K102 K103 K104 K105 K106 K107 K108 K109 K110 K111 K112 K113 K114 K115 K116 K117 K118 K119 K120 K121 K122 K123 K124 K125 K126 K127 K128 K129 K130 K131 K132 K133 K134 K135 K136 K137 K138 K139 K140 K141 K142 K143 K144 K145 K146 K147 etc
Identity
- Device Name
- Lower Limb Brace EUDAMED
- Model / Reference
- K101 K102 K103 K104 K105 K106 K107 K108 K109 K110 K111 K112 K113 K114 K115 K116 K117 K118 K119 K120 K121 K122 K123 K124 K125 K126 K127 K128 K129 K130 K131 K132 K133 K134 K135 K136 K137 K138 K139 K140 K141 K142 K143 K144 K145 K146 K147 etc EUDAMEDK101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974141901004 EUDAMED
- Basic UDI-DI
- 697414190LLB001D2 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES 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
Lower Limb Brace by Hengshui Jingkang Medical Device 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 | 697414190LLB001D2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hengshui Jingkang Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000041859
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0faf6d93-0a21-4299-9b63-4354ac4107ff 61 fields · synced Jun 18, 2026