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Caristo Diagnostics Ltd

United Kingdom (ex Northern Ireland) GB-MF-000023066 Last updated 23 May 2026

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Devices
2
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
0

Catalogue2

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • MDR 723656 Reissued

    Quality management system EU MDR

    Issued
    5 Jan 2026
    Expires
    16 Feb 2031
    Valid from
    17 Feb 2026

Related companies

Authorised representatives

Notified bodies

  • Notified body 2797

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Caristo Diagnostics US

What Caristo Diagnostics Ltd makes

Caristo Diagnostics Ltd manufactures diagnostic devices for detecting dental plaque and cardiovascular risk factors. The CaRi-Plaque system evaluates oral biofilm composition to assess plaque presence and severity, while the CaRi-Heart device analyzes biomarkers linked to cardiovascular health.

The company’s portfolio includes Class II and Class IIa medical devices, with products registered in the EU via eudamed and the FDA’s 510(k) clearance process in the United States. The company is headquartered in the United Kingdom.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Caristo Diagnostics Ltd manufacture?

Caristo Diagnostics Ltd manufactures diagnostic devices including the CaRi-Plaque system for evaluating oral biofilm composition to assess plaque presence and severity, and the CaRi-Heart device that analyzes biomarkers linked to cardiovascular health.

Where is Caristo Diagnostics Ltd based?

Caristo Diagnostics Ltd is headquartered in the United Kingdom, as indicated by the country code GB in their device registration information.

Which regulatory registries list Caristo Diagnostics Ltd's devices?

Caristo Diagnostics Ltd's devices are listed in the EU's eudamed registry and have received FDA 510(k) clearance in the United States, as per their registration information.

How are Caristo Diagnostics Ltd's devices classified?

Caristo Diagnostics Ltd manufactures Class II and Class IIa medical devices, with these classifications reflecting the level of control necessary to ensure their safety and effectiveness for diagnostic purposes.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United Kingdom (ex Northern Ireland)
Address
New Barclay House, Oxford, Oxfordshire, United Kingdom (ex Northern Ireland)
PRRC contact
James Davis
EUDAMED SRN
GB-MF-000023066