Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010242164

FEI Number

3010242164

Entity Name

HAEMOPHARM BIOFLUIDS SRL

City/State/Country

Tovo di S.Agata Sondrio, IT

Establishment Address

via Industria 6, Tovo di S.Agata Sondrio 23030, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Haemopharm Biofluids (Owner Number: 10095692)

Owner / Operator Contact Address

Via dell'Industria 6, Tovo di Sant'Agata, IT-SO 23030, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212052

PMA Number

N/A

All Registered Proprietary Names

HMB32 Dialysis Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2026-04-15

Official Correspondent

Lucrezia Pizzini

US Agent Details

Carol Ming Business: MOZARC MEDICAL US LLC Email: Carol.Ming@mozarcmedical.com Phone: (774) 2910767

Related Public Records

Same Entity

Haemopharm Biofluids

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 3010242164. Last updated year: 2026. Please use registration number 3010242164 when referencing this establishment in official correspondence.