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Insole
EUDAMEDClass I (EU MDR)
Ref 21811Model KSGP0001,KSGP0002,KSGP0004,KSGP0005,KSGP0006, KSGP0013,KSGP0007,KSGP0008,KSGP0009,KSGP0010, KSGP0015,KSGP0019,KSGP0020,KSGP0024,KSGP0025, KSGP0043,KSGP0045,KSGP0051,KSGP-SOCK001,KSGP-SOCK002, KSGP-SOCK003,KSGP-SOCK004,KSGP-SOCK005,SZCP001, KSGS1806,etc
Identity
- Device Name
- Insole EUDAMED
- Model / Reference
- KSGP0001,KSGP0002,KSGP0004,KSGP0005,KSGP0006, KSGP0013,KSGP0007,KSGP0008,KSGP0009,KSGP0010, KSGP0015,KSGP0019,KSGP0020,KSGP0024,KSGP0025, KSGP0043,KSGP0045,KSGP0051,KSGP-SOCK001,KSGP-SOCK002, KSGP-SOCK003,KSGP-SOCK004,KSGP-SOCK005,SZCP001, KSGS1806,etc EUDAMED21811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976457901426 EUDAMED
- Basic UDI-DI
- 697645790KSGPVM EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Insole by Dongguan Jinshuo Sport Products Company Limited — 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 | 697645790KSGPVM | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Jinshuo Sport Products Company Limited
- EUDAMED SRN
- CN-MF-000035270
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f94a4d7d-539e-4118-b3f5-1d6c349a86e8 61 fields · synced Jun 19, 2026