BC Universal Sealer
Ref 08.650.00.013.XX
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800123819761 08800123819761 | Date21 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Dental root canal sealing material
- Model / Reference
- 08.650.00.013.XX
- Primary DI / UDI-DI
- 08800123819761
- Basic UDI-DI
- B-08800123819761
- EMDN Code
- Q01010201 Root canal filling dental pastes
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000012442
- Authorised representative
- KTR Europe GmbH DE-AR-000005685
Other devices from Vericom Co., Ltd.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No