Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009869675

FEI Number

3009869675

Entity Name

CYTOGNOS, S.L.

City/State/Country

Santa Marta de Tormes Salamanca, ES

Establishment Address

Pol. La Serna, Km.0, Nave 9, Santa Marta de Tormes Salamanca 37900, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cytognos, S.L. (Owner Number: 10042893)

Owner / Operator Contact Address

Pol. La Serna, Km.0, Nave 9, Santa Marta de Tormes, ES-SA 37900, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CYT-16PE7+56PE-A CYT-56F-A CYT-36F3-A CYT-81AC750-A CYT-4C2-A CYT-15F4-A CYT-3PE1-A CYT-5C2-A CYT-MPOF3-A CYT-8F8-A CYT-4PE1-A CYT-45C10-A CYT-45C11-A CYT-3AC750-A CYT-3AP10-A CYT-7AP4-A CYT-10AC750-A CYT-38F-A CYT-56PE-A CYT-45F6-A CYT-KAPPPE-A CYT-45AC750-A CYT-134PE-A CYT-19C4-A CYT-4PBZ-A CYT-38F2-A CYT-20F3-A CYT-180AC750-A CYT-38AC750-A CYT-4F1-A CYT-79aPE-A CYT-138AC750-A CYT-8PE9-A CYT-LAMBF-A CYT-117AP2-A CYT-TCRGDPC7-A CYT-138PBZ-A CYT-B2MC2-A CYT-138PE4-A CYT-LAMBPE-A CYT-3C4-A CYT-138OC-A CYT-45OC-A CYT-19C8-A CYT-14AP3-A CYT-KAPPAP-A CYT-16F6-A CYT-3C9-A CYT-20PBZ-A CYT-KAPPF2-A CYT-3F9-A CYT-34C2-A CYT-LAC750-A CYT-38F2-500-A CYT-45AC750-500-A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2013-01-09

Official Correspondent

Henar Hernandez

US Agent Details

Minoti Patel Business: BD Biosciences (Becton, Dickinson and Company) Email: Minoti.Patel@Bd.Com Phone: (408) 9660787

Related Public Records

Same Entity

Cytognos, S.L.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009869675. Last updated year: 2026. Please use registration number 3009869675 when referencing this establishment in official correspondence.