Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613419

FEI Number

3000168341

Entity Name

HMC Premedical S.p.A.

City/State/Country

MIRANDOLA Modena, IT

Establishment Address

Via Bosco 1/3, MIRANDOLA Modena 41037, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HMC Group (Owner Number: 9041724)

Owner / Operator Contact Address

Via Bosco 1/3, --, Mirandola, IT-MO 41037, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242917

PMA Number

N/A

All Registered Proprietary Names

BA02BL ENFit Bottle Adapter 15mm-16.5mm - Bulk BA03L ENFit Bottle Adapter 18mm-19.5mm BA02L ENFit Bottle Adapter 15mm-16.5mm BA07L ENFit Bottle Adapter 10.5mm-11mm BA06L ENFit Bottle Adapter 20mm-21.5mm BA01BL ENFit Stepped Bottle Adapter - Bulk BA03BL ENFit Bottle Adapter 18mm-19.5mm - Bulk BA04L ENFit Bottle Adapter 25.5mm-27mm BA08L ENFit Bottle Adapter 16.5mm-18mm BA04BL ENFit Bottle Adapter 25.5mm-27mm - Bulk BA01L ENFit Stepped Bottle Adapter BA05L ENFit Bottle Adapter 18.5mm-20.5mm B-SMART PRESSURE MANOMETER B-SMART Enteral Drainage System, Enteral Medicine straw

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2018-05-03
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2006-05-05
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

HMC Group

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613419. Last updated year: 2026. Please use registration number 9613419 when referencing this establishment in official correspondence.