Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011802635

FEI Number

3011802635

Entity Name

KIRO GRIFOLS, S.L.

City/State/Country

Arrasate-Mondragon Guipuzcoa, ES

Establishment Address

Polo de Innovacion Garaia, Goiru Kalea 1, Edificio B, Arrasate-Mondragon Guipuzcoa 20500, ES

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

KIRO GRIFOLS, S.L. (Owner Number: 10049581)

Owner / Operator Contact Address

Polo de Innovacion Garaia, Goiru Kalea 1, Edificio B, Arrasate-Mondragon, ES-SS 20500, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152441

PMA Number

N/A

All Registered Proprietary Names

KIRO Oncology US KIRO Link KIRO Fill US KIRO Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2015-06-23
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2016-01-18

Official Correspondent

Borja Lizari

US Agent Details

Nuria Sola Tapias Business: Grifols USA, LLC Email: nuria.solatapias@grifols.com Phone: (213) 3043852

Related Public Records

Same Entity

KIRO GRIFOLS, S.L.

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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Similar Registrations

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3006227536	ARxIUM Inc.	WINNIPEG Manitoba, CA
3006153342	Omnicell S.R.L.	TRIESTE, IT
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011802635. Last updated year: 2026. Please use registration number 3011802635 when referencing this establishment in official correspondence.