Patient monitor
by Guangdong Biolight Meditech Co., Ltd 20 variants
Ref Q5Model Q3, Q5, Q7, TRUSCOPE Ultra Q3, TRUSCOPE Ultra Q5, TRUSCOPE Ultra Q7, PG S30, PG S50, PG S70, LM7
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 | Number69325623100043X 06932562300134 | Date27 Dec 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- Withdrawn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
- Model / Reference
- Q3, Q5, Q7, TRUSCOPE Ultra Q3, TRUSCOPE Ultra Q5, TRUSCOPE Ultra Q7, PG S30, PG S50, PG S70, LM7
- Primary DI / UDI-DI
- 06932562300134
- Basic UDI-DI
- 69325623100043X
- EMDN Code
- Z1203020201 Multi–parameter patient bedside monitors
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000006333
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Guangdong Biolight Meditech Co., Ltd
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No