Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710641

FEI Number

3003565456

Entity Name

SEI Medical S.A. de C.V.

City/State/Country

Juarez Chihuahua, MX

Establishment Address

ROBERTO FIERRO #6420 & FRANCISCO SARABIA, PARQUE INDUSTRIAL AEROPUERTO, Juarez Chihuahua 32685, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SEISA MEDICAL INC. d.b.a Tekni-Plex Healthcare (Owner Number: 9047964)

Owner / Operator Contact Address

615 S. DUPONT HIGHWAY, Dover, DE 19901, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Compass Health Brand Corporation AMEDA INC. Scott Specialties, Inc. COOK INC. Bard Peripheral Vascular, Inc. ELASTIC THERAPY INC AMEDA INC. SCOTT SPECIALTIES, INC. SCOTT SPECIALTIES, INC. Burpee Medsystems, LLC OLYMPUS GYRUS Scott Specialties, Inc. COMPASS HEALTH International Biomedical LTD Scott Specialties, Inc. Compass Health Brand Corporation Scott Specialties, Inc. HOLLISTER INC ELASTIC THERAPY LLC COMPASS HEALTH WILSON-COOK MEDICAL, INC AMEDA INC. COOK MEDICAL INC COOK MEDICAL INC SCOTT SPECIALTIES, INC. Philips Medical Systems International BV (Burpee Medsystems, LLC) Compass Health Brand Corporation AMEDA INC. Compass Health Brand Corporation Cook Incorporated HOLLISTER INC COOK VASCULAR, INC WILSON COOK Compass Health Brand Corporation SCOTT SPECIALTIES, INC. COMPASS HEALTH BRANDS Compass Health Brand Corporation COOK UROLOGICAL, INC. MEDI-DYNE Scott Specialties, Inc. Scott Specialties, Inc. Scott Specialties, Inc. COMPASS HEALTH HOLLISTER INC SCOTT SPECIALTIES, INC. OLYMPUS GYRUS DermaClip® US, LLC HOLLISTER INC AMEDA INC. HOLLISTER INC COMPASS HEALTH COOK MEDICAL INC Compass Health Brand Corporation Compass Health Brand Corporation Compass Health Brand Corporation COOK UROLOGY INC AMEDA INC.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRX	Case, Contact Lens	Ophthalmic	Class 2	886.5928	2020-02-11
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2010-11-22
FQJ	Support, Scrotal, Therapeutic	General Hospital	Class 1	880.5820	2020-01-06
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2022-11-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-01-02
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	Class 1	890.3475	2026-04-21
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2010-11-22
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2010-11-22
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2018-05-08
HSQ	Belt, Pelvic, Traction	Orthopedic	Class 1	888.5890	2016-09-01
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2020-07-06
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2013-10-21
KMO	Binder, Elastic	General Hospital	Class 1	880.5160	2018-03-22
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-11-07
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-12-12
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2020-11-20
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2020-06-29
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2018-03-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-11-19
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-12-11
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2019-10-09
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2011-02-25
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2010-11-19
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2011-04-25
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2011-04-25
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2016-08-31
QCT	Scaffold, Dissection Repair	Unknown	Class 3	N/A	2021-05-21
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2020-06-29
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2010-11-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-01-28
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-09-26
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2010-12-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-10-09
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2010-11-22
CAM	Yoke Assembly, Medical Gas	Anesthesiology	Class 1	868.6885	2020-06-29
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-08-31
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2019-10-03
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2020-05-05
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2014-10-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2014-10-09
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-06-28
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2010-11-22
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2019-08-14
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2010-11-22
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2025-08-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-11-19
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2018-11-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2013-10-21
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2024-12-16
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2010-12-22
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2014-01-10
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2010-11-19
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2020-01-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2011-04-08
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-02-13
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2020-06-29
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-06-29
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2011-04-25
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2011-05-16

Official Correspondent

Cesar Rios

US Agent Details

Cesar Coughanour Business: SEI Medical - TekniPlex Healthcare Email: cesar.coughanour@seisa.com Phone: (915) 7744321

Related Public Records

Same Entity

SEISA MEDICAL INC. d.b.a Tekni-Plex Healthcare

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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710641. Last updated year: 2026. Please use registration number 9710641 when referencing this establishment in official correspondence.