X-Ray Disc
by Polident d.o.o. Industrija dentalnih proizvodov 7 variants
Ref PMMR.479, PMMR.508, PMMR.468, PMMR.610, PMMR.507, PMMR.506, PMMR.478, PMMR.469, PMMR.504, PMMR.600, PMMR.471, PMMR.650, PMMR.477, PMMR.474
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 | Number++EPOLQ01992A | Date17 Apr 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- Withdrawn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
- PMMR.479, PMMR.508, PMMR.468, PMMR.610, PMMR.507, PMMR.506, PMMR.478, PMMR.469, PMMR.504, PMMR.600, PMMR.471, PMMR.650, PMMR.477, PMMR.474
- Primary DI / UDI-DI
- +EPOLPMMR4790Q, +EPOLPMMR5080J, +EPOLPMMR4680O, +EPOLPMMR6100D, +EPOLPMMR5070I, +EPOLPMMR5060H, +EPOLPMMR4780P, +EPOLPMMR4690P, +EPOLPMMR5040F, +EPOLPMMR6000C, +EPOLPMMR4710I, +EPOLPMMR6500H, +EPOLPMMR4770O, +EPOLPMMR4740L
- Basic UDI-DI
- ++EPOLQ01992A
- Direct Marketing DI
- +EPOLPMMR4790Q+EPOLPMMR5080J+EPOLPMMR4680O+EPOLPMMR6100D+EPOLPMMR5070I+EPOLPMMR5060H+EPOLPMMR4780P+EPOLPMMR4690P+EPOLPMMR5040F+EPOLPMMR6000C+EPOLPMMR4710I+EPOLPMMR6500H+EPOLPMMR4770O+EPOLPMMR4740L
- EMDN Code
- Q0199 Odontology devices - other
- Device Class
- Class I
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- SI-MF-000000740
Other devices from Polident d.o.o. Industrija dentalnih proizvodov
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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