Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225580

FEI Number

3012349753

Entity Name

SMC Ltd.

City/State/Country

Devens, MA, US

Establishment Address

18 Independence Dr, Devens, MA 01434, 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

PROSOFT-PED-S PROSOFT-INF PROSOFT-XL PROSOFT-ADULT PROSOFT-PRE PROSOFT-INT-INF PROSOFT-NEO PROSOFT-PED-AS PROSOFT-PED-S1 (SMC India) UNICORN-INF (SMC India) UNICORN-PED (SMC India) UNICORN-ADULT (SMC India) PROSOFT-PED-AS1 (SMC India) Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-10-05
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2025-12-16
PQX	Epinephrine Syringe	General Hospital	Class 2	880.5860	2018-11-06

Official Correspondent

No official correspondent registered.

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
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

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3015084765	GUANG DONG EDA TECHNOLOGY CO., LTD.	Dongguan City Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225580. Last updated year: 2026. Please use registration number 1225580 when referencing this establishment in official correspondence.