510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Claritas Healthtech Limited

London London, City of, GB

CLARITAS HEALTHTECH LIMITED appears in FDA device records in London London, City of, GB. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Claritas Healthtech Limited between 2021 and 2025. The busiest year on record is 2021, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Claritas Healthtech Limited, by decision year
YearClearances
20212
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K244016iPETcertum (v1.0)LLZSubstantially Equivalent
K213140Claritas iPETLLZSubstantially Equivalent
K212470iRADLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Claritas Healthtech Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30309791553030979155CLARITAS HEALTHTECH LIMITED120 Regent Street, London London, City of W1B 5FE GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain