Shyicare
by Shyi Shin Industrial CO., LTD 20 variants
Ref 918001Model 918001~918294, 918001F~918294F, 918033H, 918D08, 918018-SE, 918078-SE
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 | Number471989221QGG0918LK | Date10 Dec 2025 | 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- Withdrawn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
- Gel Positioning Pads
- Model / Reference
- 918001~918294, 918001F~918294F, 918033H, 918D08, 918018-SE, 918078-SE, 918001
- Primary DI / UDI-DI
- 04719892211017, 04719892211024
- Basic UDI-DI
- 471989221QGG0918LK
- EMDN Code
- V080302 Patient positioning medical cushions
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000031683
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Shyi Shin Industrial CO., LTD
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: 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