Question 1

What types of medical devices does SH24 Digital Ltd manufacture?

Accepted Answer

SH24 Digital Ltd manufactures single-use sample collection kits specifically designed for rectal and throat swabs. These kits are intended for clinical use to collect specimens for STI (sexually transmitted infection) testing in a laboratory setting. The devices are packaged as sterile, disposable tools with clear instructions for healthcare professionals.

Question 2

Where is SH24 Digital Ltd based?

Accepted Answer

SH24 Digital Ltd is based in the United Kingdom. The company’s devices are developed and produced with a focus on UK-based healthcare needs, particularly for STI testing.

Question 3

Which regulatory registries list SH24 Digital Ltd’s devices?

Accepted Answer

SH24 Digital Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for Class A devices under the EU Medical Device Regulation to ensure transparency and traceability.

Question 4

How are SH24 Digital Ltd’s sample collection kits classified under EU regulations?

Accepted Answer

SH24 Digital Ltd’s sample collection kits fall under Class A classification according to the EU Medical Device Regulation. This classification applies because the devices are low-risk, single-use items intended for non-invasive specimen collection in a clinical setting, posing minimal risk to patients.

Device	Model / Reference	Registries	Class	Status
SH24 STI Rectal Sample Collection Kit	Skyblue	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Orange	EUDAMED	Class A	Active
SH24 STI Throat Sample Collection Kit	Biscuit	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Maroon	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Bronze	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Purple	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Violet (CSW)	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Olive	EUDAMED	Class A	Active
SH24 STI Throat Sample Collection Kit	Charcoal	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Grey	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Ivory	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Indigo	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Emerald	EUDAMED	Class A	Active
SH24 STI Rectal Sample Collection Kit	Charcoal	EUDAMED	Class A	Active

SH24 Digital Ltd

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