Portable Dental Unit
by Henan Olive Electronic Technology Co., Ltd.
Ref HR-DP15, HR-DP14
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697604328PD01JR | Date23 Sep 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- HR-DP15, HR-DP14
- Primary DI / UDI-DI
- 06976043280027, 06976043280034
- Basic UDI-DI
- 697604328PD01JR
- Direct Marketing DI
- 0697604328002706976043280034
- EMDN Code
- Z12110101 Dental treatment units
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000031828
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Henan Olive Electronic Technology 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