HAEMOTRONIC DE MEXICO S DE RL

FDA Device Registration & Listing · REYNOSA Tamaulipas, MX · Registration 3014936217

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014936217
FEI Number
3014936217
Entity Name
HAEMOTRONIC DE MEXICO S DE RL
City/State/Country
REYNOSA Tamaulipas, MX
Establishment Address
AVENIDA MIKE ALLEN 1011 A, PARQUE INDUSTRIAL REYNOSA, REYNOSA Tamaulipas 88780, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HAEMOTRONIC DE MEXICO S DE RL (Owner Number: 10058807)
Owner / Operator Contact Address
AVENIDA MIKE ALLEN 1011 A, PARQUE INDUSTRIAL REYNOSA, REYNOSA, MX-TAM 88780, MX
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RCEZKS RCEZ1T RCQT RS1 430-40 SB1KLE LRF10S BPFAPLUS BPFBLA BPFB LRF10BLA LRFP LRF6BLA 736-21 732-33M 732-83 732-37M 732-32M 732-82 732-42M 400-03E

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAK Microfilter, Blood Transfusion General Hospital Class 2 880.5440 2025-08-12
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2026-06-15
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2020-12-21
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2018-10-30
CAK Microfilter, Blood Transfusion General Hospital Class 2 880.5440 2025-08-12
CAK Microfilter, Blood Transfusion General Hospital Class 2 880.5440 2025-08-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-08-05
CAK Microfilter, Blood Transfusion General Hospital Class 2 880.5440 2025-08-12
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2026-05-27
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2025-08-12
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2026-06-15
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2026-05-27
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2025-08-12
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2020-07-27
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2020-07-27
MZC System, Detection, Bacterial, For Platelet Transfusion Products Microbiology Class 1 866.2560 2025-08-12
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2026-06-15
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2023-10-30
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2026-05-27

Official Correspondent

Jaziel VALLADARES

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

HAEMOTRONIC DE MEXICO S DE RL
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
K873873 Travenol Laboratories, S.A. RESUBMITTED MICRON TRANSFUSION FILTER 1987-10-22
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number Establishment Name Location
9612051 FENWAL INTERNATIONAL, INC. HAINA San Cristobal, DO
3037389071 GVS TM, INC. Covina, CA, US
1066733 CHARTER MEDICAL, LLC Winston Salem, NC, US
3017174574 GVS FILTER TECHNOLOGY DE MEXICO Apodaca N.L Nuevo Leon, MX
3004404323 MACO PHARMA MOUVAUX Hauts-de-France, FR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014936217. Last updated year: 2026. Please use registration number 3014936217 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.