Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005910889

FEI Number

3005910889

Entity Name

SCIENTIFIC MOLDING CORPORATION, LTD. DBA SMC LTD.

City/State/Country

Amery, WI, US

Establishment Address

9000 Griffin Street East, Amery, WI 54001, 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

Nebulizing Elbow Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-01-08

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
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
3000143502	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Somerset, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Similar Registrations

Registration Number	Establishment Name	Location
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005910889. Last updated year: 2026. Please use registration number 3005910889 when referencing this establishment in official correspondence.