Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039353681

FEI Number

3039353681

Entity Name

BYONYKS PVT LTD

City/State/Country

Lahore Punjab, PK

Establishment Address

45/A Khayaban-e-Iqbal, DHA 3 XX Block, Lahore Punjab 54000, PK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Byonyks Pvt Ltd (Owner Number: 10093647)

Owner / Operator Contact Address

45/A Khayaban-e-Iqbal, DHA 3 XX Block, Lahore, PK-PB 54000, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Byonyks Automated PD Set DS-1 Byonyks X-1 APD Cycler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2025-06-17
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2025-06-17

Official Correspondent

Eric Flachbart

US Agent Details

Eric Flachbart Business: Byonyks Medical Devices Inc. Email: eric@byonyks.com Phone: (813) 9973230

Related Public Records

Same Entity

Byonyks Pvt Ltd

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
K822361	Travenol Laboratories, S.A.	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	1982-08-16
K933687	R & D Batteries, Inc.	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	1994-02-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Z-0017-05	Fresenius Medical Care North America	2	Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034

Similar Registrations

Registration Number	Establishment Name	Location
3038277270	BYONYKS MEDICAL DEVICES INC	Itasca, IL, US
3003865400	Maruho Plastic Solutions	ERIE, CO, US
3015335038	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039353681. Last updated year: 2026. Please use registration number 3039353681 when referencing this establishment in official correspondence.