Kera
by Huzur Dental Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ 15 variants
Ref SAT4-20000
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 | Number8682276255SAT4-20000TJ 08682276255579 | Date17 Dec 2022 | 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- Withdrawn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
- Synthetic Plaster Type 4
- Model / Reference
- SAT4-20000
- Primary DI / UDI-DI
- 08682276255579
- Basic UDI-DI
- 8682276255SAT4-20000TJ
- Direct Marketing DI
- 08682276255579
- EMDN Code
- Q0101010201, Q0101010202, Q0101010203, Q0101010204, Q0101010299
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000019287
Other devices from Huzur Dental Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
See all devices from Huzur Dental Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →
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