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Insole
EUDAMEDClass I (EU MDR)
Ref JS2318Model 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 EUDAMEDJS2318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976457901662 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Insole by Dongguan Jinshuo Sport Products Company Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 30debc68-b16e-4899-ad84-b138cd0926af 61 fields · synced Jun 18, 2026