MyHealthChecked
by Concepta Diagnostics EUDAMED
Active
Ref B5000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506075735B5000SV | Date3 Mar 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- MyHealthChecked Blood Sample Collection Kit – Gold Tube (Home Use – Single Test)
- Model / Reference
- B5000
- Primary DI / UDI-DI
- 05060757350051
- Basic UDI-DI
- 506075735B5000SV
- EMDN Code
- W0501010201 Capillary blood collection systems
- Device Class
- Class I
- Medical Purpose
- Blood Sample Collection Kit – Gold Tube (Home Use – Single Test) Thyroid Profile Blood Sample Collection Kit (Home Use – Single Test) Vitamins & Minerals Profile Blood Sample Collection Kit (Home Use – Single Test) Menopause Profile Blood Sample Collection Kit (Home Use – Single Test) Polycystic Ovary Syndrome (PCOS) Blood Sample Collection Kit (Home Use – Single Test) Female Fertility Blood Sample Collection Kit (Home Use – Single Test) Progesterone Blood Sample Collection Kit (Home Use – Single Test)
Manufacturer details
- EUDAMED SRN
- GB-PR-000033063