Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003767629

FEI Number

3003767629

Entity Name

TECNOLOGIAS MEDICAS INNOVADORAS S DE RL

City/State/Country

H. MATAMOROS Tamaulipas, MX

Establishment Address

CALLE 18 Y HERRERA No. 84, ZONA CENTRO,, H. MATAMOROS Tamaulipas C.P. 87300, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRE HOLDING, INC. (Owner Number: 9008012)

Owner / Operator Contact Address

2412 PARI Way, --, Midlothian, VA 23112, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092560

PMA Number

N/A

All Registered Proprietary Names

Bubbles the Fish LC Disposable O-PEP Vortex LC Plus Vios Filter/Valve Set NASAL SHOWER PARI PEP Trek S SinuStar Vios Pro Proneb Ultra Proneb Max WING TIP TUBING PARI Baby Nebulizer PARI Sinus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2005-03-07
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2012-03-13
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2017-05-31
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-29
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-01-15
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-12-22
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-12-14
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2006-09-27
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2006-09-15
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-11-29
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-01-15
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2005-09-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2020-05-19
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2020-05-19
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2006-09-15
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-12-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2011-12-22

Official Correspondent

MICHAEL JUDGE

US Agent Details

MICHAEL JUDGE Business: PRE HOLDING, INC. Email: MIKE.JUDGE@PARI.COM Phone: (804) 2537274

Related Public Records

Same Entity

PRE HOLDING, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2954963	PARI RESPIRATORY EQUIPMENT, INC.	MIDLOTHIAN, VA, 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
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

Similar Registrations

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3010272829	Salter Labs de Mexico de S.A. de C.V.	Chihuahua Mexico, MX
3010205626	Globalcare Medical Technology HK, Ltd.	Hong Kong, HK
1043214	DEROYAL INDUSTRIES, INC.	POWELL, TN, US
3014610488	NINGBO YINGMED MEDICAL INSTRUMENTS CO.,LTD.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003767629. Last updated year: 2026. Please use registration number 3003767629 when referencing this establishment in official correspondence.