alginate impression material
by Across Industrial Co., Ltd 10 variants
Ref 250318Model 250301/250302/250303/250304/250305/250306/250307/ 250308/ 250309 /250310 /250311 /250312 /250313 /250314/ 250315/ 250316 /250317 /250318 /250319/ 250320
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 | Number697842977ZWAIM63 06978429770177 | Date18 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- Withdrawn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
- alginate impression material
- Model / Reference
- 250301/250302/250303/250304/250305/250306/250307/ 250308/ 250309 /250310 /250311 /250312 /250313 /250314/ 250315/ 250316 /250317 /250318 /250319/ 250320, 250318
- Primary DI / UDI-DI
- 06978429770177
- Basic UDI-DI
- 697842977ZWAIM63
- EMDN Code
- Q01020101 Dental impression alginates
- 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