MyHealthChecked

by Concepta Diagnostics EUDAMED

Active European Union

Ref B7000

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number506075735B7000TB Basic UDI-DI	Date3 Mar 2023Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: Blood & Urine Sample Collection Kit (Home Use – Single Test)
Model / Reference: B7000

Primary DI / UDI-DI: 05060757350082
Basic UDI-DI: 506075735B7000TB
EMDN Code: W05019099 Samples collection devices - other

Device Class: Class I
Medical Purpose: Male Sexual Health Blood & Urine Sample Collection Kit (Home Use – Single Test) Female Sexual Health Blood & Urine Sample Collection Kit (Home Use – Single Test)

Manufacturer details

EUDAMED SRN: GB-PR-000033063

Other devices from Concepta Diagnostics

Blood Sample Collection Kit (Gold)

Class I
Blood Sample Collection Kit (Lavender)

Class I
Urine & Two Site Swab Sample Collection Kit (Rectal/Throat)

Class I
Urine Sample Collection Kit

Class I
Three Site Swab Sample Collection Kit (Vaginal/Rectal/Throat)

Class I
Single Site Swab Sample Collection Kit (Vaginal)

Class I

See all devices from Concepta Diagnostics →

Properties

Sterile