MILESTONE S.P.A.

FDA Device Registration & Listing · Sorisole Bergamo, IT · Registration 1000391282

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000391282
FEI Number
1000391282
Entity Name
MILESTONE S.P.A.
City/State/Country
Sorisole Bergamo, IT
Establishment Address
Via Fatebenefratelli 1/5, Sorisole Bergamo 24010, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MILESTONE S.P.A. (Owner Number: 10023724)
Owner / Operator Contact Address
Via Fatebenefratelli, 1/5, Sorisole, IT-BG 24010, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HISTODREAM EW HISTODREAM TM HISTODREAM DM HISTODREAM CM MCC, Milestone Cryoembedding Compound MLD4323 1818-10 MLD4436-7 MLD4436-5 MLD3939 3333-5 MLD3022-7 MLD4234-10 MLD4442 4436-10 SMALL TIP SPATULA MLD3939 3333-10 MLD3426-7 MLD50 2520-5 MLD5951-10 MLD3228 2926-7 MLD4410-7 MLD3228 2926-10 LENS PAPER DISC 30 MLD3328 2926-7.5 MLD3022-10 MLD5951-5 LENS PAPER DISC 22 MLD4415-5 Presto CHILL MLD4436-7A MLD4415-10 MLD2618-7 MLD4436-10A Flash FREEZE MLD4436-5A MLD3330 2419-7 MLD4323 1818-5 MLD4323 1818-7 MLD4415-7 MLD2618-5 MLD4439 3434-10 MLD5951-7 LENS PAPER DISC 16 LARGE TIP SPATULA MLD3030 2525-7 MLD3426-10 MLD3330 2419-5 MLD2618-10 MLD3426-5 MLD4129 3324-10 MLD3330 2419-10 MLD4129 3324-5 MLD3228 2936-5 MLD3030 2525-10 MLD3022-5 MLD4129 3324-7 MLD4234-5 MLD4442 4436-5 MLD4410-10 MLD3030 2525-5 MLD4410-5 MLD4436-10 MLD4234-7 MLD4442 4436-7 MLD3939 3333-7 ProCUT XL/5 station LeanSTATION Bx ProCUT XL/5 KIT SealSAFE CUTMATE 3mm forceps tissue block eGROSS pro-x Dome complete XL/5 120mm Dome complete XXL/5 140mm WorkSTATION Bx 140 CheckLITE CUTMATE 4mm forceps tissue block Dome complete XL/5 100mm TissueSAFE WorkSTATION CUTMATE Starter KIT Dome complete XXL/5 120mm ProCUT Starter KIT ProCUT P/5 KIT Foam boards XL/5 80mm ProCUT XXL/5 KIT Dome Complete P/5 60mm eGROSS Foam Boards P/5 40mm Foam boards XXL/5 100mm ROSESTATION ProCUT XXL/5 station Foam boards XL/5 120mm ProCUT P/5 ProCUT XXL/5 CUTMATE 2mm forceps tissue block Foam Boards P/5 60mm Dome complete XXL/5 100mm CUTMATE 2/3/4mm forcep tissue block Foam boards XXL/5 120mm Dome complete XL/5 60mm WorkSTATION Bx Foam boards XXL/5 140mm WorkSTATION 140 Dome Complete P/5 40mm Foam boards XL/5 100mm CUTMATE Calibration device ProCUT XL/5 RoseSTATION Dome complete XL/5 80mm CUTMATE 4 forceps ProCUT P/5 Station CUTMATE 2,3,4, 2/3/4mm Foam boards XL/5 60mm SM-SPACER 2MM ULTRASAFE HISTODREAM EW HISTODREAM TM HISTODREAM DM HISTODREAM CM MLD4323 1818-10 MLD4436-7 MLD4436-5 MLD3939 3333-5 MLD3022-7 MLD4234-10 MLD4442 4436-10 SMALL TIP SPATULA MLD3939 3333-10 MLD3426-7 MLD50 2520-5 MLD5951-10 MLD3228 2926-7 MLD4410-7 MLD3228 2926-10 LENS PAPER DISC 30 MLD3328 2926-7.5 MLD3022-10 MLD5951-5 LENS PAPER DISC 22 MLD4415-5 Presto CHILL MLD4436-7A MLD4415-10 MLD2618-7 MLD4436-10A Flash FREEZE MLD4436-5A MLD3330 2419-7 MLD4323 1818-5 MLD4323 1818-7 MLD4415-7 MLD2618-5 MLD4439 3434-10 MLD5951-7 LENS PAPER DISC 16 LARGE TIP SPATULA MLD3030 2525-7 MLD3426-10 MLD3330 2419-5 MLD2618-10 MLD3426-5 MLD4129 3324-10 MLD3330 2419-10 MLD4129 3324-5 MLD3228 2936-5 MLD3030 2525-10 MLD3022-5 MLD4129 3324-7 MLD4234-5 MLD4442 4436-5 MLD4410-10 MLD3030 2525-5 MLD4410-5 MLD4436-10 MLD4234-7 MLD4442 4436-7 MLD3939 3333-7 FineFIX Vacuum bag extra large Vacuum bag small Vacuum bag medium Vials 30ml Vacuum bag SU Small TissueTRAYS Vials 200ml Vacuum bag SU Large Vials 1.5ml Vacuum bag large ULTRASAFE TRANSPARENT BUCKET 1L ULTRASAFE TRANSPARENT BUCKET 3L – Box 40 ULTRASAFE BUCKET 1L ULTRASAFE TRANSPARENT BUCKET 5L ULTRASAFE TRANSPARENT BUCKET 3L ULTRASAFE BUCKET 1L – Box 120 ULTRASAFE BUCKET 3L ULTRASAFE BUCKET 5L – Box 25 ULTRASAFE TRANSPARENT BUCKET 1L – Box 120 ULTRASAFE TRANSPARENT BUCKET 5L – Box 25 ULTRASAFE BUCKET 3L – Box 40 ULTRASAFE BUCKET 5L ULTRASAFE BUCKET 10L ULTRASAFE BUCKET 10L – Box 25 FORMSAFE HistoDream CRIO PLUS HistoDream CRIO Presto JFC Solution HISTODREAM M HISTODREAM AM HISTODREAM M HISTODREAM AM Mol-DECALCIFIER MCC, Milestone Cryoembedding Compound Vacuum bag extra large Vacuum bag small Vacuum bag medium Vials 30ml Vacuum bag SU Small TissueTRAYS Vials 200ml Vacuum bag SU Large Vials 1.5ml Vacuum bag large ULTRASAFE TRANSPARENT BUCKET 1L ULTRASAFE TRANSPARENT BUCKET 3L – Box 40 ULTRASAFE BUCKET 1L ULTRASAFE TRANSPARENT BUCKET 5L ULTRASAFE TRANSPARENT BUCKET 3L ULTRASAFE BUCKET 1L – Box 120 ULTRASAFE BUCKET 3L ULTRASAFE BUCKET 5L – Box 25 ULTRASAFE TRANSPARENT BUCKET 1L – Box 120 ULTRASAFE TRANSPARENT BUCKET 5L – Box 25 ULTRASAFE BUCKET 3L – Box 40 ULTRASAFE BUCKET 5L ULTRASAFE BUCKET 10L ULTRASAFE BUCKET 10L – Box 25 FORMSAFE ProCUT XL/5 station LeanSTATION Bx ProCUT XL/5 KIT SealSAFE CUTMATE 3mm forceps tissue block eGROSS pro-x Dome complete XL/5 120mm Dome complete XXL/5 140mm WorkSTATION Bx 140 CheckLITE CUTMATE 4mm forceps tissue block Dome complete XL/5 100mm TissueSAFE WorkSTATION CUTMATE Starter KIT Dome complete XXL/5 120mm ProCUT Starter KIT ProCUT P/5 KIT Foam boards XL/5 80mm ProCUT XXL/5 KIT Dome Complete P/5 60mm eGROSS Foam Boards P/5 40mm Foam boards XXL/5 100mm ROSESTATION ProCUT XXL/5 station Foam boards XL/5 120mm ProCUT P/5 ProCUT XXL/5 CUTMATE 2mm forceps tissue block Foam Boards P/5 60mm Dome complete XXL/5 100mm CUTMATE 2/3/4mm forcep tissue block Foam boards XXL/5 120mm Dome complete XL/5 60mm WorkSTATION Bx Foam boards XXL/5 140mm WorkSTATION 140 Dome Complete P/5 40mm Foam boards XL/5 100mm CUTMATE Calibration device ProCUT XL/5 RoseSTATION Dome complete XL/5 80mm CUTMATE 4 forceps ProCUT P/5 Station CUTMATE 2,3,4, 2/3/4mm Foam boards XL/5 60mm SM-SPACER 2MM ULTRASAFE Mol-DECALCIFIER JFC Solution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IDW Dispensers, Paraffin Pathology Class 1 864.3010 2019-05-21
KEQ Media, Mounting, Water Soluble Pathology Class 1 864.4010 2015-12-21
MXT Device, Accessory, Cooling Plate For Tissue Embedding Station Pathology Class 1 864.3010 2015-12-21
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2015-12-21
IDW Dispensers, Paraffin Pathology Class 1 864.3010 2019-05-21
MXT Device, Accessory, Cooling Plate For Tissue Embedding Station Pathology Class 1 864.3010 2015-12-21
LDZ Fixative, Alcohol Containing Pathology Class 1 864.4010 2015-12-22
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2015-12-21
IDP Microtome, Cryostat Pathology Class 1 864.3010 2025-11-28
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2015-12-21
PPM General Purpose Reagent Pathology Class 1 864.4010 2015-12-22
IDO Microtome, Rotary Pathology Class 1 864.3010 2021-01-18
IDO Microtome, Rotary Pathology Class 1 864.3010 2021-01-18
KDY Agent, Chelating For Decalcification Pathology Class 1 864.4010 2015-12-21
KEQ Media, Mounting, Water Soluble Pathology Class 1 864.4010 2015-12-21
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2015-12-21
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2015-12-21
KDY Agent, Chelating For Decalcification Pathology Class 1 864.4010 2015-12-21
PPM General Purpose Reagent Pathology Class 1 864.4010 2015-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

Elia Rosetta Email: e.rosetta@milestonemed.com Phone: (269) 4884950

Related Public Records

Same Entity

MILESTONE S.P.A.
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
K761138 Zeus Scientific, Inc. FA TISSUE FIXATIVE & WASH SET 1978-01-06
K842913 E K Ind., Inc. WRIGHT STAIN FIXATIVE 1984-09-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0039-2012 Richard-Allan Scientific Company 1
Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000391282. Last updated year: 2026. Please use registration number 1000391282 when referencing this establishment in official correspondence.
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