Spine surgery device
by Ningbo Techart Medical Equipment Co., Ltd.
Ref MDTJ-001
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 | Number697542033SSD001JA | Date28 Sep 2026 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Spine surgery device
- Model / Reference
- MDTJ-001
- Primary DI / UDI-DI
- 06975420333530
- Basic UDI-DI
- 697542033SSD001JA
- EMDN Code
- Z12011299 Patient positioning instruments – other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000008851
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Ningbo Techart Medical Equipment 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