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Toe Straightener toe Seperator
EUDAMEDClass I (EU MDR)
Ref N/AModel JHZ-044Model JHZ-041Model IM-INSModel JF-194 (IM-INS-XS)Model JF-194 (IM-INS-S)Model JF-194 (IM-INS-XL)
Identity
- Device Name
- Toe Straightener toe Seperator EUDAMEDPremium Orthotic Insole EUDAMEDPremium Orthotic Insoles EUDAMED
- Model / Reference
- JHZ-044 EUDAMEDN/A EUDAMEDJHZ-041 EUDAMEDIM-INS EUDAMEDJF-194 (IM-INS-XS) EUDAMEDJF-194 (IM-INS-S) EUDAMEDJF-194 (IM-INS-XL) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976425574287 EUDAMED06976425574256 EUDAMED06976425574249 EUDAMED
- Basic UDI-DI
- 697642557ts0116L EUDAMED697642557ts0086X EUDAMED697642557in4242M EUDAMED697642557in4252P EUDAMED697642558in42636 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDGermany 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
Toe Straightener toe Seperator 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 | 697642557ts0116L | 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 (6)
- EUDAMED 544c6115-43dd-42ea-aac2-e6a1b0496059 61 fields · synced Oct 6, 2026
- EUDAMED 1db4106b-b931-4f81-9c4e-5fbade8dbbe0 61 fields · synced May 17, 2026
- EUDAMED 8aa9c5d6-8339-485f-b88d-23d9658f935f 61 fields · synced May 19, 2026
- EUDAMED 5a943c74-e931-4080-bfb9-ac0027e85930 61 fields · synced Jul 20, 2026
- EUDAMED d56886f2-97bd-4279-9093-f61bb89b471b 61 fields · synced Jul 23, 2026
- EUDAMED b5b9cdfc-febb-43be-abdb-8c3c56352796 61 fields · synced Jul 29, 2026