Matrixes
by FKG Dentaire Sàrl 18 variants
Ref 04.204.00.015.AC, 04.203.00.105.AC, 04.207.00.103.AC, 04.210.00.103.AC, 04.309.00.105.AC, 04.204.00.105.AC, 04.309.00.015.AC, 04.209.00.015.AC, 04.208.00.013.AC, 04.202.00.015.AC, 04.309.00.103.AC, 04.205.00.015.AC, 04.202.00.105.AC, 04.206.00.013.AC, 04.203.00.015.AC, 04.309.00.013.AC, 04.201.00.105.AC, 04.209.00.013.ACModel 04.200.00.015.AC
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 | Number7640142410101008N | Date16 Jan 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- Withdrawn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
- Model / Reference
- 04.200.00.015.AC, 04.204.00.015.AC, 04.203.00.105.AC, 04.207.00.103.AC, 04.210.00.103.AC, 04.309.00.105.AC, 04.204.00.105.AC, 04.309.00.015.AC, 04.209.00.015.AC, 04.208.00.013.AC, 04.202.00.015.AC, 04.309.00.103.AC, 04.205.00.015.AC, 04.202.00.105.AC, 04.206.00.013.AC, 04.203.00.015.AC, 04.309.00.013.AC, 04.201.00.105.AC, 04.209.00.013.AC
- Primary DI / UDI-DI
- 07640142422051, 07640142426653, 07640142422181, 07640142422365, 07640142422433, 07640142426660, 07640142422396, 07640142422273, 07640142422204, 07640142422020, 07640142422426, 07640142422068, 07640142426646, 07640142422082, 07640142422037, 07640142422389, 07640142426639, 07640142422266
- Basic UDI-DI
- 7640142410101008N
- EMDN Code
- Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000017925
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from FKG Dentaire Sàrl
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