Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009985040

FEI Number

3009985040

Entity Name

Spellman de Mexico Plant 3

City/State/Country

Matamoros Tamaulipas, MX

Establishment Address

Avenida Chapultepec, #101, Parque Industrial Finsa Oriente, Matamoros Tamaulipas 87340, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SPELLMAN HIGH VOLTAGE ELECTRONICS CORP. (Owner Number: 9003965)

Owner / Operator Contact Address

475 WIRELESS BLVD., --, Hauppauge, NY 11788, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Spellman de Mexico Spellman de Mexico

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1994-05-10
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	1994-05-10

Official Correspondent

Peter Iasso

US Agent Details

Peter Iasso Business: SPELLMAN HIGH VOLTAGE ELECTRONICS CORP. Email: piasso@spellmanhv.com Phone: (631) 6303165

Related Public Records

Same Entity

SPELLMAN HIGH VOLTAGE ELECTRONICS CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2429877	SPELLMAN HIGH VOLTAGE ELECTRONICS CORP.	HAUPPAUGE, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23

Similar Registrations

Registration Number	Establishment Name	Location
3042255107	Micro X-ray Technology (Suzhou) Co., Ltd	suzhou Jiangsu, CN
3014205374	Varex Imaging Equipment (China) Co., LTD	Wuxi Jiangsu, CN
3006789424	Hangzhou Kailong Medical Instruments Co., Ltd.	Hangzhou Zhejiang, CN
3000275399	Siemens Healthineers AG	RUDOLSTADT Thuringia, DE
3017616637	MINGWEI MEDICAL TECHNOLOGY(SUZHOU) CO.,LTD	Suzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009985040. Last updated year: 2026. Please use registration number 3009985040 when referencing this establishment in official correspondence.