Splint
by Zhangjiagang Xiehe Medical Apparatus&Instruments Co., Ltd. 9 variants
Ref YXH-12Model YXH-12,YXH-8D,YXH-9,YXH-10,YXH-8B,YXH-9A,YXH-9B,XH-15A,XH-15B,XH-15C,MALLEBLE SPLINT
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6974580870003DS 06974580878066 | Date8 May 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Splint
- Model / Reference
- YXH-12, YXH-8D, YXH-9, YXH-10, YXH-8B, YXH-9A, YXH-9B, XH-15A, XH-15B, XH-15C, MALLEBLE SPLINT
- Primary DI / UDI-DI
- 06974580878066
- Basic UDI-DI
- 6974580870003DS
- EMDN Code
- M03050299 Bandages and splints - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000008449
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No