Impression Tray
by Huanghua Promisee Dental Co.Ltd. 52 variants
Ref TI0202Model IT01,IT0101,IT0102,IT0103,IT0104,IT0105,IT0106,IT0107,IT0108,IT0109,IT0110,IT02,IT0201,IT0202,IT0203,IT0204,IT0205,IT0206,IT0207,IT0208,IT0209,IT0210,IT05,IT07,BT,BT01,BT02,BT03,BT04,BT05,IT08,IT06,TB01,TB01L,TB01M,TB01S,BP01,BP02,BP03,BP04, BP04B
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 | Number69544540IMTR001WH 06954454004487 | Date11 Mar 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- Withdrawn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
- Model / Reference
- IT01, IT0101, IT0102, IT0103, IT0104, IT0105, IT0106, IT0107, IT0108, IT0109, IT0110, IT02, IT0201, IT0202, IT0203, IT0204, IT0205, IT0206, IT0207, IT0208, IT0209, IT0210, IT05, IT07, BT, BT01, BT02, BT03, BT04, BT05, IT08, IT06, TB01, TB01L, TB01M, TB01S, BP01, BP02, BP03, BP04, BP04B, TI0202
- Primary DI / UDI-DI
- 06954454004487
- Basic UDI-DI
- 69544540IMTR001WH
- EMDN Code
- Q010503 Impression material trays, single-use
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000014766
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Huanghua Promisee Dental 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