INSTRUMENTS BOX WITH LID 200x100x50mm
Ref D-193-195Model DENTAL Hollowware instruments
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 | Number896110404HOLLOW/CLASSI75 08961104044692 | Date23 Jun 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- Withdrawn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
- DENTAL Hollowware instruments, D-193-195
- Primary DI / UDI-DI
- 08961104044692
- Basic UDI-DI
- 896110404HOLLOW/CLASSI75
- EMDN Code
- Q010399 Surgical dental devices - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- PK-MF-000031202
- Authorised representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Other devices from Mark One Surgical
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