Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005488444

FEI Number

3005488444

Entity Name

BIOKOSMES SRL

City/State/Country

BOSISIO PARINI,LECCO, IT

Establishment Address

VIA DEI LIVELLI 1, BOSISIO PARINI,LECCO 23842, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIOKOSMES SRL (Owner Number: 9080188)

Owner / Operator Contact Address

Via Dei Livelli 1, Bosisio Parini,Lecco, IT-LC 23842, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aloclair Oral Rinse, Canker-X Rincinol Mouth Sore Rinse (Aloclair Oral Rinse) Promiseb Topical Cream Nexodyn Antimicrobial Wound Care Solution Gelclair Aloclair Oral Gel, Canker-X Mouth Sore Gel (Aloclair Oral Gel)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2005-12-05
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2010-10-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-10-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-02-01
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2010-11-16
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2010-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

BIOKOSMES SRL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3013576473	ALLIANCE PHARMA SRL	Milan Lombardy, IT
3004146122	MAXIGEN BIOTECH, INC.	Taoyuan City, TW
2518467	ACCUPAC, LLC	MAINLAND, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005488444. Last updated year: 2026. Please use registration number 3005488444 when referencing this establishment in official correspondence.