Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005770916

FEI Number

3005770916

Entity Name

Parker Industrial S de RL de CV

City/State/Country

Tijuana Baja California, MX

Establishment Address

Blvd Bellas Artes 20394, Lote 12 D, Manzana 22, Ciudad Industrial, Tijuana Baja California 22444, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Parker Industrial S de RL de CV (Owner Number: 10081632)

Owner / Operator Contact Address

Blvd Bellas Artes 20394, Lote 12 D, Manzana 22, Ciudad Industrial, Tijuana, MX-BCN 22444, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ElectroSurgical, Cutting and Coagulation and Accessories TC-Bard/P, TC-COL-2, TC-CSI-5P, TC-EH, TC- Heart, TC-Maclah, TC-NK/BSM, TC-PRU, TC-SAR-3M, TC-SE/Hemo, TC-SHI-2, TC-Stoc Bath probe Cable- SP5030 Computer, Diagnostic, Pre-programmed, Single-Function RyMed Technologies RyMed Technologies SP4035-1, SP4044-35 36IN, SP4042, SP4044-15 36IN, SP4044-25 12IN, SP4045, SP4046, SP4046-1, SP4043, Catheter, Intravascu ElectroSurgical, Cutting and Coagulation and Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-02-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-03-26
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2024-03-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-05-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-05-06
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2024-02-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-03-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-20

Official Correspondent

Carlos Vazquez

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Parker Industrial S de RL de CV

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

Similar Registrations

Registration Number	Establishment Name	Location
3032912826	KMD SURGICAL SOLUTIONS, INC.	Winston Salem, NC, US
3017435705	CENTESE, INC.	Omaha, NE, US
1057421	GRACE MEDICAL, INC.	Memphis, TN, US
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005770916. Last updated year: 2026. Please use registration number 3005770916 when referencing this establishment in official correspondence.