Absorbent Paper Point
by Hubei Guarddent Medical Technology Co., Ltd
Ref 02 taper (15#)Model 02 taper (15#, 20#, 25#, 30#, 35#, 40#, 45#, 50#, 55#, 60#, 70#, 80#, mixed 15#-40#), 04 taper (15#, 20#, 25#, 30#, 35#, 40#), 06 taper (15#, 20#, 25#, 30#, 35#, 40#), F series Protaper (F1, F2, F3, F4, F5)
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 | Number697565200APP001FA 06975652002006 | Date26 Jun 2024 | 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- Withdrawn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
- Absorbent Paper Point
- Model / Reference
- 02 taper (15#, 20#, 25#, 30#, 35#, 40#, 45#, 50#, 55#, 60#, 70#, 80#, mixed 15#-40#), 04 taper (15#, 40#), 06 taper (15#, F series Protaper (F1, F2, F3, F4, F5), 02 taper (15#)
- Primary DI / UDI-DI
- 06975652002006
- Basic UDI-DI
- 697565200APP001FA
- EMDN Code
- Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000028116
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Hubei Guarddent Medical Technology Co., Ltd
See all devices from Hubei Guarddent 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