Orthopedic Casting Tape
by Jiangsu Senolo Medical Technology Co., Ltd. 5 variants
Model XD1,XD2,XD3,XD4,XD5,XD6
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69525344CAST100MU | Date13 Apr 2023 | StatusActive |
| United States | GUDID listing GUDID | Number16952534411115 | Date6 Apr 2023 | StatusListed |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Senolo
- Generic Name
- Cast construction material
- Device Name
- Orthopedic Casting Tape
- Model / Reference
- XD1, XD2, XD3, XD4, XD5, XD6
- Primary DI / UDI-DI
- 16952534411115, 16952534411160
- Basic UDI-DI
- 69525344CAST100MU
- FDA Product Code
- ITG
- EMDN Code
- M03050202 Synthetic cast bandages and splints
- GMDN Term
- Cast construction material
- Device Class
- Class I
- Regulation Number
- 890.3025
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | XD1,XD2,XD3,XD4,XD5,XD6 | XD6 |
Manufacturer details
- EUDAMED SRN
- CN-MF-000008281
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Jiangsu Senolo Medical Technology Co., Ltd.
See all devices from Jiangsu Senolo Medical Technology Co., Ltd. →
Properties
Other properties (20)
- Sterile: No
- Implantable: No
- Reusable: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Serial Number: No