Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015462350

FEI Number

3015462350

Entity Name

SKY Medical, a.s.

City/State/Country

Samorin Trnavsky, SK

Establishment Address

Vicenzy 24/2058, Samorin Trnavsky 931 01, SK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SKY Medical, a.s. (Owner Number: 10060326)

Owner / Operator Contact Address

Vicenzy 24/2058, Samorin, SK-TA 931 01, SK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Closed antineoplastic and hazardous drug reconstitution and transfer system Closed antineoplastic and hazardous drug reconstitution and transfer system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2022-03-21
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2022-03-21

Official Correspondent

Yulia Surinova

US Agent Details

Matthew R. Dryden Business: ProMedic Consulting LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

SKY Medical, a.s.

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 3015462350. Last updated year: 2026. Please use registration number 3015462350 when referencing this establishment in official correspondence.