articulating paper
by Across Industrial Co., Ltd 5 variants
Ref 242411, 242409, 242413, 242401, 242408, 242403, 242405, 242404, 242410, 242407Model 242401/242402/242403/242404/242405/242406/242407/242408/242409/242410/242411/242412/242413/242414/242415
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 | Number697842977ZWAP3R | Date20 Apr 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- Withdrawn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
- articulating paper
- Model / Reference
- 242401/242402/242403/242404/242405/242406/242407/242408/242409/242410/242411/242412/242413/242414/242415, 242411, 242409, 242413, 242401, 242408, 242403, 242405, 242404, 242410, 242407
- Primary DI / UDI-DI
- 06978429779064, 06978429779040, 06978429779088, 06978429778968, 06978429779033, 06978429778982, 06978429779002, 06978429778999, 06978429779057, 06978429779026, 06978429778975
- Basic UDI-DI
- 697842977ZWAP3R
- EMDN Code
- Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
- Device Class
- Class I
- EU market of registration
- ItalyAustria
Manufacturer details
- EUDAMED SRN
- CN-MF-000047003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Across Industrial 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