Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9618003

FEI Number

3003264198

Entity Name

CONVATEC DOMINICAN REPUBLIC, INC.

City/State/Country

Haina San Cristobal, DO

Establishment Address

CARRETERA SANCHEZ, KM. 18.5, PARQUE INDUSTRIAL ITABO, S.A., Buildings 8A, 23, 29, 30, Haina San Cristobal 91000, DO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ConvaTec (Owner Number: 2241599)

Owner / Operator Contact Address

7815 National Service Road, Suite 600, Greensboro, NC 27409, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LITTLE ONES SUR-FIT Plus Two-Piece Close End Pouch ESTEEM Synergy+ Closed Pouch NATURA SUR-FIT Closed-End Pouch with Filter STOMADRESS Plus ACTIVE LIFE One-Piece Closed-End Pouch LITTLE ONES Two-Piece Adhesive Coupling Technology NATURA SUR-FIT Closed-End Mini Pouch NATURA SUR-FIT Closed-End Pouch SUR-FIT Plus Closed-End Pouch Two-Piece EsteemBody Closed Pouch Ostomy System SUR-FIT Plus Closed-End Pouch with Filter ESTEEM+ Soft CONVEX NATURA+ Closed Pouch ESTEEM+ Closed Pouch Visi-Flow Irrigation Sleeve SUR-FIT Irrigation Sleeve Visi-Flow Irrigation Sleeve Tail Closure AQUACEL Ag Surgical SP AQUACEL Ag Advantage Surgical SP Natura SUR-FIT Irrigation Visi-Flow Irrigator Visi-Flow Irrigation System Visi-Flow Stoma Cone Visi-Flow Irrigator Set SUR-FIT NATURA Durahesive Skin Barrier/Pouch Unit Dose Kits ESTEEM Synergy Professional Kit - Non-Sterile EsteemBody Drainable Pouch Ostomy System Eakin Fistual and Wound Pouches ESENTA Strips Esteem + Drainable Pouch Trio Diamonds GentleTouch System OR Kit - Colostomy ESTEEM+ One-Piece Pouch Stomahesive Skin Barrier Kit Natura + Drainable Pouch SUR-FIT NATURA Stomahesive Skin Barrier/Pouch Unit Dose Kits ESTEEM Synergy Professional Kit - Loop Ostomy System - Sterile NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod NATURA Post-Operative Kits GentleTouch System OR Kit - Ileostomy and Urostomy NATURA Drainable and Urostomy Post-Operative Kits NATURA Stomahesive CTF Skin Barrier and Urostomy Kit Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Flexi-Seal FMS Collection Bags ESTEEM+ Soft CONVEX ActiveLife CONVEX One-Piece Drainable Pouch with Durahesive NATURA SUR-FIT High Output Drainable Pouch SUR-FIT Plus Drainable Pouch Two-Pieces SUR-FIT NATURA Drainable Pouch STOMADRESS Plus ActiveLife One-Piece Drainable Pouch with Stomahesive SUR-FIT NATURA Stomahesive NATURA SUR-FIT Drainable Pouch with InvisiClose Outlet COMBIHESIVE 2S LITTLE ONES One-Piece Drainable Pouch AutoLock SUR-FIT Drainable Pouch LITTLE ONES Two-Pieces Adhesive Coupling Technology ESTEEM SYNERGY Drainable Pouch SUR-FIT NATURA Drainable Pouch with Filter ActiveLife One-Piece Drainable Pouch with Durahesive NATURA+ Drainable Pouch LITTLE ONES Two-Pieces Drainable Pouch ESTEEM Synergy+ Drainable Pouch ESTEEM+ Drainable Pouch ActiveLife One-Piece Drainable Pouch with Durahesive Plus Loop Ostomy Rod Flexi-Seal PROTECT Fecal Management System with ENFIT Flexi-Seal PROTECT Fecal Management System Flexi-Seal FMS Collection Bags SUR-FIT NATURA Urostomy Pouch with Accuseal Tap NATURA+ Urostomy Pouch SUR-FIT System Night Drainage Container ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive SUR-FIT NATURA Urostomy Pouch ESTEEM SYNERGY Urostomy Pouch with Accuseal Tap ACTIVE LIFE One-Piece Urostomy Pouch Durahesive EsteemBody Urostomy Pouch Ostomy System ESTEEM Urostomy Pouch SUR-FIT Plus Urostomy Pouch Two-Piece Night Drainage Container Tubing Little Ones SUR-FIT NATURA Urostomy Pouch Two-Piece Ostomy System ESTEEM+ Urostomy Pouch Durahesive ESTEEM+ Soft CONVEX LITTLE ONES One-Piece Urostomy Pouch Esenta Stomahesive Protective Powder ESTEEM SYNERGY Durahesive Moldable Convex with Flexible Collar NATURA Stomahesive Moldable NATURA SUR-FIT Durahesive Wafer SUR-FIT Plus Stomahesive Wafer Two-Piece NATURA Durahesive Moldable LITTLE ONES Two Piece Stomahesive with Flexible collar NATURA SUR-FIT Stomahesive Wafer with Flexible Collar NATURA Durahesive Accordion Flange SENSI-CARE Barrier Wipes NATURA SUR-FIT Durahesive Moldable Convex with Flange SUR-FIT Plus Stomahesive Wafer NATURA Stomahesive Accordion Flange AutoLock SUR-FIT Stomahesive FLEXIBLE Wafer ESTEEM SYNERGY Stomahesive ESTEEM SYNERGY Stomahesive Moldable NATURA SUR-FIT Durahesive with Convex-It Wafer with Convexity ESTEEM SYNERGY Stomahesive with Flexible Collar NATURA SUR-FIT Stomahesive Wafer ESENTA Barrier Pump Spray NATURA Durahesive Moldable Accordion Flange LITTLE ONES Two-Piece Adhesive Stomahesive with Flexible Hydrocolloid Collar Stomahesive Paste EASE Strips ESENTA Barrier Spray ESENTA Barrier Wipes Stomahesive Strips SUR-FIT Plus Stomahesive Wafer with Flexible Collar Stomahesive Powder AutoLock SUR-FIT Durahesive FLEXIBLE Wafer Stomahesive Seal NATURA SUR-FIT Durahesive Flexible Wafer with Flexible Collar SUR-FIT Plus Durahesive with Convex-It Wafer LITTLE ONES Two-Piece Adhesive Stomahesive SENSI-CARE Barrier Spray Stomahesive Wafer NATURA Stomahesive Moldable Accordion Flange SUR-FIT NATURA Moldable Stomahesive with Hydrocolloid Flexible Collar Esenta Stomahesive Paste Esenta Stomahesive Seal CombiDERM Non-Adhesive Sterile Dressing AQUACEL Surgical ConvaFoam Silicone ConvaFoam Border CombiDERM ACD Sterile Dressing KALTOSTAT Alginate ConvaMax SUPERABSORBER Versiva AQUACEL Burn Aquacel ConvaFiber CarboFlex Versiva XC Adhesive Versiva XC Non-adhesive ConvaFoam Non-Adhesive AQUACEL Hydrofiber AQUACEL Foam AQUACEL Extra AQUACEL Extra Hydrofiber Dressing AQUACEL Foam Pro SUR-FIT NATURA Disposable Convex Insert Visi-FLow Irrigation Adapter Faceplate SUR-FIT Plus Straight Tail Closures DuoLock Curved Tail Closure ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier Visi-Flow Irrigation Sleeve Tail Closure SUR-FIT NATURA Flange Cap with Filter Visi-Flow Irrigation Sleeve DIAMONDS Gelling and Odour Control Sachets ESENTA Lubricating Deodorant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2005-06-06
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2007-11-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-01-25
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2005-06-06
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2005-06-06
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-06-24
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2007-05-17
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2016-12-19
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-03-30
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2016-12-09
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2005-06-06
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-05-17
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2006-01-31
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1992-11-17

Official Correspondent

Jared Ragone

US Agent Details

Courtney Smith Business: ConvaTec Email: courtney.smith@convatec.com Phone: (603) 2470255

Related Public Records

Same Entity

ConvaTec

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005778470	UNOMEDICAL S.R.O.	MICHALOVCE Kosicky, SK
1000317571	CONVATEC LIMITED	Deeside Flintshire, GB
3012881740	ConvaTec Canada Ltd.	Dorval Quebec, CA
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB
3011987967	ConvaTec, Inc.	Greensboro, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

Similar Registrations

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3006709396	AMPARO MEDICAL TECHNOLOGIES, INC.	Anaheim, CA, US
3019865496	Dongguan Kangda Medical Technology Co., Ltd	Dongguan Guangdong, CN
9617198	SALTS HEALTHCARE LIMITED	ASTON BIRMINGHAM, GB
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9618003. Last updated year: 2026. Please use registration number 9618003 when referencing this establishment in official correspondence.