Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009327445

FEI Number

3009327445

Entity Name

SMC Costa Rica Division S.R.L.

City/State/Country

El Coyol Alajuela, CR

Establishment Address

Building B48, Ave 0, Zona Franca Coyol, El Coyol Alajuela 20101, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SCIENTIFIC MOLDING CORPORATION LTD (Owner Number: 9057460)

Owner / Operator Contact Address

330 SMC DRIVE, --, Somerset, WI 54025, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Minimed Sil-Serter Infusion Set Insertion System, Model 385 MiniMed Quick-Serter PhotonSaber Y, Bulb Tip PhotonSaber F, 8Fr, Long, Teardrop PhotonSaber F, 12Fr, Standard, Round PhotonSaber F, 12Fr, Long, Round PhotonSaber F, 8Fr, Standard, Teardrop PhotonSaber Y, Metal Tip PhotonSaber Y, Taper Tip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2024-10-28
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2012-05-01
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2020-12-02
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2017-04-25
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2020-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Bryan Moris Business: SCIENTIFIC MOLDING CORPORATION LTD Email: Bryan.Moris@smcltd.com Phone: (715) 5239687

Related Public Records

Same Entity

SCIENTIFIC MOLDING CORPORATION LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005910889	SCIENTIFIC MOLDING CORPORATION, LTD. DBA SMC LTD.	Amery, WI, US
1225580	SMC Ltd.	Devens, MA, US
3006467300	SMC Medical Manufacturing Private Limited	BANGALORE Karnataka, IN
3010034260	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Santa Rosa, CA, US
3000143502	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Somerset, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3010034260	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Santa Rosa, CA, US
3006330030	Hologic, Inc.	Marlborough, MA, US
3008468035	MICROCUBE, LLC	Fremont, CA, US
1222780	HOLOGIC, INC.	Marlborough, MA, US
3011011193	MINERVA SURGICAL, INC.	Santa Clara, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009327445. Last updated year: 2026. Please use registration number 3009327445 when referencing this establishment in official correspondence.