prophy cup
by Across Industrial Co., Ltd 33 variants
Ref 240613Model 240601/240602/240603/240604/240605/240606/240607/240608/240609/240610/240611/240612/240613/240614/240615/240616/240617/240618/240619/240620/240621/240622/240623/2406011/2406012/2406013/2406014/2406015/2406016/2406017/2406018/2406019/2406020
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 | Number697842977ZWPC4C 06978429772737 | 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- Withdrawn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
- prophy cup
- Model / Reference
- 240601/240602/240603/240604/240605/240606/240607/240608/240609/240610/240611/240612/240613/240614/240615/240616/240617/240618/240619/240620/240621/240622/240623/2406011/2406012/2406013/2406014/2406015/2406016/2406017/2406018/2406019/2406020, 240613
- Primary DI / UDI-DI
- 06978429772737
- Basic UDI-DI
- 697842977ZWPC4C
- EMDN Code
- Q010502 Dental polishing cups, single-use
- Device Class
- Class I
- EU market of registration
- Austria
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