Hengwei
by Harbin Hengwei Technology Co., Ltd. 9 variants
Ref HW-LED700+500, HW-503-E, HW-503-BModel HW-LED700+500 HW-LED700+700 HWLED500+500 HW-LED700 HW-LED500 HW-LED700M HW-LED500M HW-LED700+700+700 HW-LED500+500+500 HW-LED300 HW-LED400 HW-LED300M etc, HW-503-A HW-503-B HW-503-C HW-503-C1 HW-503-D HW-503-D1 HW-503-D2 HW-503-D3 HW-503-D4 HW-503-D5 HW-503-E etc
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 | Number697683364HWOLVT | Date24 Oct 2023 | 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- Withdrawn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
- Device Name
- Operating LightOperating Table
- Model / Reference
- HW-LED700+500 HW-LED700+700 HWLED500+500 HW-LED700 HW-LED500 HW-LED700M HW-LED500M HW-LED700+700+700 HW-LED500+500+500 HW-LED300 HW-LED400 HW-LED300M etc, HW-LED700+500, HW-503-A HW-503-B HW-503-C HW-503-C1 HW-503-D HW-503-D1 HW-503-D2 HW-503-D3 HW-503-D4 HW-503-D5 HW-503-E etc, HW-503-E, HW-503-B
- Primary DI / UDI-DI
- 06976833641007, 06976833640109, 06976833640017
- Basic UDI-DI
- 697683364HWOLVT, 697683364HWOTWB
- EMDN Code
- Z12010701, Z12010702, Z12010780, Z12010785, Z12010799, Z12011202
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000038308
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Harbin Hengwei Technology Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: 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