Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020616

FEI Number

3002806476

Entity Name

Merit Medical Singapore Pte. Ltd.

City/State/Country

SINGAPORE Central Singapore, SG

Establishment Address

198 YISHUN AVE. 7, SINGAPORE Central Singapore 768926, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Merit Medical Systems, Inc. (Owner Number: 1721504)

Owner / Operator Contact Address

1600 West Merit Parkway, --, South Jordan, UT 84095, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K936182

PMA Number

N/A

All Registered Proprietary Names

Exacta Percutaneous Sheath Introducer Integral Injectate Temperature Probe Catheter Connection Cable Disposable In Line Sensor Housing Safedraw Blood Sampling System Secalon T Catheter Careflow Central Venous Catheter ROSE Tubing, Fluid Delivery Critiflo Dome Critiflo Connecta PE Lines Spectraject Control Syringe Critikit Plus In-Line Room/ Ice Injectate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-02-17
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2017-02-17
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2017-02-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-17
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2017-02-17
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2017-02-17
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-02-17
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2017-02-17
DQF	Actuator, Syringe, Injector Type	Cardiovascular	Class 2	870.1670	2017-02-17
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2017-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

John Knorpp Business: Merit Medical Systems, Inc. Email: jknorpp@merit.com Phone: (801) 2084795

Related Public Records

Same Entity

Merit Medical Systems, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021179744	VIEW POINT MEDICAL, INC.	Carlsbad, CA, US
3012276280	KA Medical	Arden Hills, MN, US
2032338	Merit Medical Systems, Inc.	ALISO VIEJO, CA, US
1125782	MERIT MEDICAL SYSTEMS, INC	Chester, VA, US
9615728	BIOSPHERE MEDICAL, S.A.	Roissy Val-d'Oise, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0027-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020616. Last updated year: 2026. Please use registration number 8020616 when referencing this establishment in official correspondence.