impression tray
by Across Industrial Co., Ltd 60 variants
Ref 240703Model 240701/240702/240703/240704/240705/240706/240707/240708/240709/240710/240711/240712/240713/240714/240715/240716/240717/240718/240719/240720/240721/240722/240723/240724/240725/240726/240727 etc
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 | Number697842977ZWIT4R 06978429773147 | 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- Withdrawn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
- impression tray
- Model / Reference
- 240701/240702/240703/240704/240705/240706/240707/240708/240709/240710/240711/240712/240713/240714/240715/240716/240717/240718/240719/240720/240721/240722/240723/240724/240725/240726/240727 etc, 240703
- Primary DI / UDI-DI
- 06978429773147
- Basic UDI-DI
- 697842977ZWIT4R
- EMDN Code
- Q010503 Impression material trays, 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