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

Danderyd Stockholm, SE

NEKO HEALTH AB appears in FDA device records in Danderyd Stockholm, SE. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. 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
2
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Neko Health AB in 2026.

Clearances by year, as a table
510(k) clearance decisions for Neko Health AB, by decision year
YearClearances
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254129Spectrum-2MUDSubstantially Equivalent
K253911Derma-2LHQSubstantially Equivalent

Registered establishments

FDA registered establishments for Neko Health AB, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30421656713042165671NEKO HEALTH ABEkensbergsvagen 117, Solna 171 41 SE2026
30431906903043190690NEKO HEALTH INC524 Broadway, New York, NY 10012 US2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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