Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003313105

FEI Number

3003313105

Entity Name

BIO-OPTICA MILANO SPA

City/State/Country

MILANO, IT

Establishment Address

VIA SAN FAUSTINO, 58, MILANO 20134, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIO-OPTICA MILANO SPA (Owner Number: 9075939)

Owner / Operator Contact Address

VIA SAN FAUSTINO, 58, --, MILANO, IT-NOTA 20134, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alkaline phosphatase 10 ml ATPase 10 ml NADH diaphorase 10 ml Cytochrome C oxidase 10 ml Phosphorylase 10 ml Acid phosphatase 10 ml Phosphofructokinase 10 ml Succinic dehydrogenase 10 ml Myoadenylate deaminase 10 ml Non specific Esterase 10 ml Bio Mold BCP230 - Freezing plate BCP170 - Cooling plate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2015-06-08
KER	Container, Embedding	Pathology	Class 1	864.3010	2015-06-05
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2015-06-05

Official Correspondent

CINZIA MARENGHI

US Agent Details

James Tentler Business: STAT LAB Email: JTentler@statlab.com Phone: (800) 4223573

Related Public Records

Same Entity

BIO-OPTICA MILANO SPA

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 3003313105. Last updated year: 2026. Please use registration number 3003313105 when referencing this establishment in official correspondence.