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Splint
EUDAMEDClass I (EU MDR)
Ref YHR-F02Model YHR-F02, YHR-F03, YHR-F04, YHR-F05, YHR-F06, YHR-F07, YHR-F08, YHR-F09, YHR-F10, YHR-ED01, YHR-ED02, YHR-TG1, YHR-TG2
Identity
- Device Name
- Splint EUDAMED
- Model / Reference
- YHR-F02, YHR-F03, YHR-F04, YHR-F05, YHR-F06, YHR-F07, YHR-F08, YHR-F09, YHR-F10, YHR-ED01, YHR-ED02, YHR-TG1, YHR-TG2 EUDAMEDYHR-F02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974583360001 EUDAMED
- Basic UDI-DI
- 697458336HRSPLINTX3 EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER 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
Splint by ZhangJiaGang Herui Medical Equipment 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 | 697458336HRSPLINTX3 | Class I | Active |
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Manufacturer
- Manufacturer
- ZhangJiaGang HeRui Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000003397
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 45c7b644-5d71-4783-8832-21c687b6a3a2 61 fields · synced Jun 18, 2026