dental wedge
by Across Industrial Co., Ltd 29 variants
Ref 241004Model 241001/241002/241003/241004/241005/241006/241007/241008/241009/241010/241011/241012/241013/241014/241015/241016/241017/241018/241019/241020/241021/241022/241023/241024/241025/241026/241027/241028/241029/241030
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 | Number697842977ZWDW4G 06978429774755 | Date15 Apr 2025 | 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- Withdrawn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
- dental wedge
- Model / Reference
- 241001/241002/241003/241004/241005/241006/241007/241008/241009/241010/241011/241012/241013/241014/241015/241016/241017/241018/241019/241020/241021/241022/241023/241024/241025/241026/241027/241028/241029/241030, 241004
- Primary DI / UDI-DI
- 06978429774755
- Basic UDI-DI
- 697842977ZWDW4G
- EMDN Code
- Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
- Device Class
- Class I
- EU market of registration
- Italy
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