The Injection of Slilcon Rubber
by Debo Medical Technology (Shijiazhuang) Co., Ltd.
Ref 7001Model 7001、7001S、7002、7003、7005、7010、7011、7012、7014、7015、7016、7018、7016NOTIP、7016TIPS、7018TIPS、NT085、NT086、7055R、7055W、7066 or customized
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 | Number697700234TIOSR001BH 06977002349014 | Date20 Jan 2026 | 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- Withdrawn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
- The Injection of Slilcon Rubber
- Model / Reference
- 7001、7001S、7002、7003、7005、7010、7011、7012、7014、7015、7016、7018、7016NOTIP、7016TIPS、7018TIPS、NT085、NT086、7055R、7055W、7066 or customized, 7001
- Primary DI / UDI-DI
- 06977002349014
- Basic UDI-DI
- 697700234TIOSR001BH
- EMDN Code
- Q010599 Dental instruments, single-use - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039157
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Debo Medical Technology (Shijiazhuang) Co., Ltd.
See all devices from Debo Medical Technology (Shijiazhuang) 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