Hirayer
by Shanghai Hirayer Medical Technology Co., Ltd 5 variants
Ref HHS-500
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 | Number698020682001G5 06980206820012 | Date15 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- Withdrawn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
- Device Name
- Operating Lamp
- Model / Reference
- HHS-500
- Primary DI / UDI-DI
- 06980206820012
- Basic UDI-DI
- 698020682001G5
- EMDN Code
- Z12010701 Fixed scialytic lamps
- Device Class
- Class I
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- CN-MF-000026901
- Authorised representative
- Humiss Beratung GmbH DE-AR-000023447
Other devices from Shanghai Hirayer Medical Technology Co., Ltd
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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