Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002772505

FEI Number

3002772505

Entity Name

DIAGNOSTIC GRIFOLS, S.A.

City/State/Country

PARETS DEL VALLES Barcelona, ES

Establishment Address

PASSEIG FLUVIAL, 24, PARETS DEL VALLES Barcelona 08150, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIAGNOSTIC GRIFOLS, S.A. (Owner Number: 9050426)

Owner / Operator Contact Address

Passeig Fluvial, 24, Parets del Valles, ES-B 08150, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK190320

PMA Number

N/A

All Registered Proprietary Names

Erytra DG Gel 8 Neutral card Erytra Eflexis Grifols Diluent Grifols Wash Solution B Grifols Wash Solution A DG Clean DG THERM DG Reader Net

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2025-07-01
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2025-07-01
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2025-07-01
PBC	Manual Blood Grouping And Antibody Test Systems	Hematology	Class 2	864.9175	2013-09-03
JCB	Detergent	Pathology	Class 1	864.4010	2013-09-03
PBC	Manual Blood Grouping And Antibody Test Systems	Hematology	Class 2	864.9175	2013-09-03
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2024-04-11
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2020-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

Alisha McReynolds Email: alisha.mcreynolds@grifols.com Phone: (510) 9235046

Related Public Records

Same Entity

DIAGNOSTIC GRIFOLS, S.A.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3016014873	BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH	Grosskugel /Kabelsketal Saxony-Anhalt, DE
2032600	Grifols Diagnostic Solutions Inc.	SAN DIEGO, CA, US
8043379	STRATEC SE	BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemberg, DE
3004910133	DiaMed GmbH	Cressier Fribourg, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002772505. Last updated year: 2026. Please use registration number 3002772505 when referencing this establishment in official correspondence.