Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012187635

FEI Number

3012187635

Entity Name

NOVEM MEDICAL S. DE R.L. DE C.V.

City/State/Country

TIJUANA Baja California, MX

Establishment Address

CALLE AMAPOLAS 19380, COL LIBRAMIENTO, TIJUANA Baja California 22225, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NOVEM MEDICAL S. DE R.L. DE C.V. (Owner Number: 10049894)

Owner / Operator Contact Address

Calle Amapolas 19380, Col Libramiento, TIJUANA, MX-BCN 22225, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hope Nebulizer Assy, Extract Reag QV SARS, VIAL QUIDEL Pro-Sil Silicone Stick and Gel Shur-In: S188811 ET Tape, LockTite Ear Wash system Rigid and/or Flexible SPILL KIT Skin Marker - TIME OUT markers, Sandel Safety Marker Q Flo Valve assembly Weighted Safety Handle for Scalpel #20 Disarmer, scalpel disarmer Accutach Flow Sensor Portable Scalp Cooling System PAD, HEATING, POWERED DISARM-IT-ALL Finger Compressor CMLS-OPERATING ROOM W/CUPS Stabiltube TOPICAL SILICONE OINTMENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2018-09-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-02-11
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2021-10-29
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-04-13
NNY	Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-02-18
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2018-12-18
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2017-07-23
PXG	Spill Kit	General Hospital	Class 1	880.6890	2024-04-04
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2016-09-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-08-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-04-07
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-08-09
JAX	Pneumotachometer	Anesthesiology	Class 2	868.2550	2019-07-28
PMC	Scalp Cooling System	General, Plastic Surgery	Class 2	878.4360	2023-08-11
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2015-08-24
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-05-04
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-08-09
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-07-04
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2023-11-06
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-05-04
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2018-12-18
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-05-10

Official Correspondent

ENRIQUE CASTRO

US Agent Details

John Barron Business: Primary Packaging Email: primarypack@yahoo.com Phone: (949) 2947077

Related Public Records

Same Entity

NOVEM MEDICAL S. DE R.L. DE C.V.

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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
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
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012187635. Last updated year: 2026. Please use registration number 3012187635 when referencing this establishment in official correspondence.