Connect splint
by Suzhou Connect Medical Technology Co., Ltd.
Model 7.5cm*30cm,7.5cm*90cm, 10.0cm*40cm,10.0cm*50cm, 10.0cm*75cm,12.5cm*75cm, 12.5cm*115cm15.0cm*75cm, 15.0cm*115cm
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69509221splint0018G 16950922100016 | Date9 Oct 2022 | StatusActive |
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- Withdrawn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 — CE/MDR Active
Specification
- Device Name
- Connect splint
- Model / Reference
- 7.5cm*30cm, 7.5cm*90cm, 10.0cm*40cm, 10.0cm*50cm, 10.0cm*75cm, 12.5cm*75cm, 12.5cm*115cm15.0cm*75cm, 15.0cm*115cm
- Primary DI / UDI-DI
- 16950922100016
- Basic UDI-DI
- 69509221splint0018G
- EMDN Code
- M030505 Zimmer splints
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000029361
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Suzhou Connect Medical Technology Co., Ltd.
Properties
Other properties (13)
- 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