510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bioserenity Medical Devices Group

PARIS CEDEX 13 Ile-de-France, FR

BIOSERENITY MEDICAL DEVICES GROUP appears in FDA device records in PARIS CEDEX 13 Ile-de-France, FR. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Bioserenity Medical Devices Group in 2025.

Clearances by year, as a table
510(k) clearance decisions for Bioserenity Medical Devices Group, by decision year
YearClearances
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243788IceCap product lineGXYSubstantially Equivalent

Registered establishments

FDA registered establishments for Bioserenity Medical Devices Group, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30140277383014027738BIOSERENITY MEDICAL DEVICES GROUP6/8 rue Jean Antoine de Baif, PARIS CEDEX 13 Ile-de-France 75013 FR2026

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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What MDM checks, and what it does not

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