Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016566166

FEI Number

3016566166

Entity Name

UNION PLASTIC DIVISION APE

City/State/Country

Chateau -Landon Seine-et-Marne, FR

Establishment Address

Zone Industrielle Route De Souppes, Chateau -Landon Seine-et-Marne 77570, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Union Plastic (Owner Number: 10060826)

Owner / Operator Contact Address

ZA Robert-43-140, St Didier en Velay, FR-43 43-140, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220856

PMA Number

N/A

All Registered Proprietary Names

RAYDYLYO® Vial Adapter 13mm - 20mm MEDIC'UP® Vial Adapter 20mm MEDIC'UP® Vial Adapter 13mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-11-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-11-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-11-28

Official Correspondent

Frederic GOUNON

US Agent Details

Michael STARK Business: QS TECHNOLOGY Email: michael.stark@omerin.com Phone: (203) 2372297

Related Public Records

Same Entity

Union Plastic

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002477874	UNION PLASTIC	St Didier en Velay Haute-Loire, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016566166. Last updated year: 2026. Please use registration number 3016566166 when referencing this establishment in official correspondence.