Manufacturer

Concepta Diagnostics

United Kingdom (ex Northern Ireland)

Approvals : EU – class I, IIa

4 categories, 19 models including 19 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Capillary blood collection systems	W0501010201	Blood Sample Collection Kit (Gold) T12000 Blood Sample Collection Kit (Lavender) T15000 Boots Blood Sample Collection Kit – Gold & Lavender Tube (Home Use – Single Test) Boots Blood Sample Collection Kit – Gold Tube (Home Use Single Test) MyHealthChecked B5000 4 others MyHealthChecked B6000 Retest Blood Kit (Gold & Lavender) Retest Blood Kit (Single Gold) Retest Blood Kit (Single Lavender)	I, IIa MDR	EUDAMED record Report an error
Samples collection devices - other	W05019099	Boots DNA Sample Collection Kit (Home Use – Single Test) W4000 MyHealthChecked B7000 MyHealthChecked D3000 Single Site Swab Sample Collection Kit (Vaginal) T11000 Three Site Swab Sample Collection Kit (Vaginal/Rectal/Throat) T13000 1 other Urine & Two Site Swab Sample Collection Kit (Rectal/Throat) T14000	I MDR	EUDAMED record Report an error
Venous or arterious blood collection devices - other	W0501010199	MyHealthChecked2 refs MyHealthChecked Phlebotomy Sample Collection Kit – Gold & Lavender Tube The MyHealthChecked Phlebotomy Blood Sample Collection Kit – Gold Tube	IIa MDR	EUDAMED record Report an error
Urine collection devices - other	W05010299	Urine Sample Collection Kit T10000	I MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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