Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000143502

FEI Number

3000143502

Entity Name

SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.

City/State/Country

Somerset, WI, US

Establishment Address

330 SMC Drive, Somerset, WI 54025, US

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

CEREPAK Detacher FitLife EE Total Face Mask ATTUNE LIFEPORT KIDNEY PE Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors S 4Point Headgear with Clips RP Kit Capstrap with Clips RP Kit Performax Headgear 9 Pack Performax Headgear 5 Pack Bronchoscopy Elbow Kit FitLife SE Total Face Mask Amara View FFM Amara

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2022-07-18
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-07-18
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2018-06-12
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-11-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-08
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	Class 1	876.3500	2020-04-06
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2007-02-16
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2020-12-09
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2012-11-26
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2012-11-26
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2013-01-16
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-01-08
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2012-11-26
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-10-09
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-01-08
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-09-04
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-10-09

Official Correspondent

SHU LI

US Agent Details

No US Agent registered (Local establishment).

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
3009327445	SMC Costa Rica Division S.R.L.	El Coyol Alajuela, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951256	Target Therapeutics	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	1995-09-08
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
K013575	Organ Recovery Systems, Inc.	KPS-I, THE KIDNEY PERFUSION SOLUTION	2002-01-25

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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000143502. Last updated year: 2026. Please use registration number 3000143502 when referencing this establishment in official correspondence.