Identity
- Device Name
- INSOLE EUDAMED
- Model / Reference
- JHZ6-019 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976425574058 EUDAMED
- Basic UDI-DI
- 697642557in4052H EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Insole by Dongguan Jiuhui Industrial 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 | 697642557in4052H | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Jiuhui Industrial Limited
- EUDAMED SRN
- CN-MF-000035646
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8953ed06-56c0-42b9-9247-1eca858adeba 61 fields · synced Jun 18, 2026