Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043007473

FEI Number

3043007473

Entity Name

TECNOCIRURGICA COMERCIO DE MATERIAIS MEDICOS CIRURGICOS E HOSPITALARES LTDA

City/State/Country

Rio Claro Sao Paulo, BR

Establishment Address

RUA 22 BE, 1280, Rio Claro Sao Paulo 13501388, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TECNOCIRURGICA COMERCIO DE MATERIAIS MEDICOS CIRURGICOS E HO (Owner Number: 10094861)

Owner / Operator Contact Address

RUA 22 BE, 1280, Rio Claro, BR-SP 13501388, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

T0092 - STERILE DISPOSABLE Cover Microscope without visor T0093 - STERILE DISPOSABLE Cover Microscope with visor T5016 - Cleaning Brush Nylon/Inox 40cm/10cm/15mm T5004 - Cleaning Brush Nylon/Inox 30cm/5cm/3mm T5006 - Cleaning Brush Nylon/Inox 40cm/10cm/5mm T5011 - Cleaning Brush Nylon/Inox 40cm/10cm/10mm T3004 - STERILE DISPOSABLE Denniston Dilators T3000 - Denniston Dilators T1902 - Veress Needle SMART T2013 - Stirrup Boot Pads T0086 - STERILE DISPOSABLE EQUIPMENT COVER T0097 - STERILE DISPOSABLE Camera Cover Video T0098 - STERILE DISPOSABLE Enveloped Camera Cover Video T0027 - STERILE DISPOSABLE Mayo Cover T0043 - Insuflation Tubing With Filter and connector T0021 - Rectal Probe T0022 - Vaginal Probe T0521 - LAPAROHEPA T1700 - Catheter Colangiography

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2026-01-02
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2026-01-06
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2025-12-30
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-01-02
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2026-01-02
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2026-01-02
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2026-01-02
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2026-01-02
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2026-01-02
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2026-01-02

Official Correspondent

PRISCILA BISCARO

US Agent Details

Juliana Albuquerque Business: Tecno American Instruments Group LLC Email: juliana@americaninstruments.us Phone: (407) 2806166

Related Public Records

Same Entity

TECNOCIRURGICA COMERCIO DE MATERIAIS MEDICOS CIRURGICOS E HO

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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0040-2017	Trumpf Medical Systems, Inc.	1	Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Z-0041-2017	Trumpf Medical Systems, Inc.	1	Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.

Similar Registrations

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3016527960	Sony Global Manufacturing & Operations Corporation Kohda Site	Nukata-gun Aichi, JP
1000204638	LEICA INSTRUMENTS (SINGAPORE) PTE LTD.	SINGAPORE South West, SG
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043007473. Last updated year: 2026. Please use registration number 3043007473 when referencing this establishment in official correspondence.