Endoscope Light Source
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 6 variants
Ref HB500-TECModel HB500
Endoscope Light Source (HB500-TEC) is a Class I device made by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., registered in EUDAMED on 25 Nov 2023 (Basic UDI-DI 69449040AB065100098H), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449040AB065100098H 06903053047296 | Date25 Nov 2023 | StatusActive |
Official records
- EUDAMED public site 69449040AB065100098H
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- Withdrawn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
- Endoscope Light Source
- Model / reference
- HB500, HB500-TEC
- Primary DI / UDI-DI
- 06903053047296
- Basic UDI-DI
- 69449040AB065100098H
- EMDN code
- Z12020402 Light sources for endoscopy and minimally invasive surgery
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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