patient monitor
by Guangdong Biolight Meditech Co., Ltd 20 variants
Ref LM 18Model P12, P15, P18, P22, Truscope P12, Truscope P15, Truscope P18, Truscope P22, LM 15, LM 18
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 | Number69325623100013R 06932562301254 | Date9 May 2022 | 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- Withdrawn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
- P12, P15, P18, P22, Truscope P12, Truscope P15, Truscope P18, Truscope P22, LM 15, LM 18
- Primary DI / UDI-DI
- 06932562301254
- Basic UDI-DI
- 69325623100013R
- 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