MyHealthChecked
by Concepta Diagnostics EUDAMED
Active
Ref P4000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506075735P4000XG | Date25 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- MyHealthChecked Phlebotomy Sample Collection Kit (butterfly needle) – Gold Tube (Single Test)
- Model / Reference
- P4000
- Primary DI / UDI-DI
- 05060757350839
- Basic UDI-DI
- 506075735P4000XG
- EMDN Code
- W0501010199 Venous or arterious blood collection devices - other
- Device Class
- Class IIa
- Medical Purpose
- The MyHealthChecked Phlebotomy Blood Sample Collection Kit (butterfly needle) – Gold Tube is for use by trained phlebotomists to collect and package venous blood specimens for transport to our laboratory to analyse for a variety of tests that involve human blood. The complete Intended Use is contained in the Information Card package insert.
Manufacturer details
- EUDAMED SRN
- GB-PR-000033063