Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008244559

FEI Number

3008244559

Entity Name

CASEX, LTDA

City/State/Country

Curitiba Parana, BR

Establishment Address

Av. Fredolin Wolf, 4474, Curitiba Parana 82410, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Casex, LTDA (Owner Number: 10046440)

Owner / Operator Contact Address

Av. Fredolin Wolf, 4474, Curitiba, BR-PR 82410, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

330G Ostomy Elastic Belt large 330M Ostomy Elastic Belt medium 400 Ostomy Plastic Clamp 330P Ostomy Elastic Belt small G025 Amorphous Hydrogel with Alginate 1oz/25g G085 Amorphous Hydrogel with Alginate 3oz/85g 700 Ostomy Charcoal Filter PO30 Ostomy Powder 530 Ostomy Lubricant Deodorant 100ml 3.4oz 610 Ostomy Gel Maker 5700-45 Urostomy Pouch adhevise 2 pieces clear 5700-57 Urostomy Pouch adhevise 2pieces clear 5700-70 Urostomy Pouch adhevise 2 pieces clear 5145-00C Urostomy Pouch adhevise 1 piece clear 745-70 Wafer with adhesive 70mm 745-57 Wafer with adhesive 57mm 750-45 Wafer without adhesive 45mm SP30 Ostomy Skin Barrier 30g 1oz RA30 Ostomy Adhesive Remover 30g 1oz 750-57 Wafer without adhesive 57mm PA060 Ostomy Paste 60g 2oz 7000 Ostomy Hydrocolloid Strips 750-70 Wafer without adhesive 70mm 745-45 Wafer with adhesive 45mm RA30W Ostomy Adhesive Remover Wipes SP30W Ostomy Skin Barrier Wipes 3245-00C Drainable pouch 1piece adhesive clear 13/64mm 3245-00W Drainable pouch 1piece adhesive opaque 13/64mm 3450-00C Drainable pouch 1piece without adhesive clear 13/80mm 3450-00W Drainable pouch 1piece without adhesive opaque 13/80mm 3250-00W Drainable pouch 1piece without adhesive opaque 13/64mm 3445-00C Drainable pouch 1piece adhesive clear 13/80mm 3445-00W Drainable pouch 1piece adhesive opaque 13/80mm 3250-00C Drainable pouch 1piece without adhesive clear 13/64mm H320 Hydrocolloid Dressing Extra Thin 20x20cm / 8x8in H120 Hydrocolloid Dressing Regular 20x20cm / 8x8in H315 Hydrocolloid Dressing Extra Thin 15x20cm / 6x8in H115 Hydrocolloid Dressing Regular 15x20cm / 6x8in H112 Hydrocolloid Dressing Regular 15x15cm / 6x6in H110 Hydrocolloid Dressing Regular 10x10cm / 4x4in H218 Hydrocolloid Dressing Border 20x21cm / 8x8in H213 Hydrocolloid Dressing Border 15x18cm / 6x7in H310 Hydrocolloid Dressing Extra Thin 10x10cm / 4x4in H312 Hydrocolloid Dressing Extra Thin 15x15cm / 6x6in A 1515 Calcium Alginate Dressing 15x15cm / 6x6in A 1020 Calcium Alginate Dressing 10x20cm / 4x8in A 0230 Calcium Alginate Dressing 2x30cm / .8x12in CFT1010 Polyurethane Foam Tracheostomy Dressing 10x10cm / 4x4in CF060607 Polyurethane Foam Dressing 6x6cm / 3x3in HC1515 Hydro Fiber Dressing 15x15cm / 6x6in HC0505 Hydro Fiber Dressing 5x5cm / 2x2in A 0505 Calcium Alginate Dressing 5x5cm / 2x2in A 1010 Calcium Alginate Dressing 10x10cm / 4x4in CF2020 Polyurethane Foam Dressing 20x20cm / 8x8in HC1010 Hydro Fiber Dressing 10x10cm / 4x4in CF1010 Polyurethane Foam Dressing 10x10cm / 4x4in CFT2020 Polyurethane Foam Tracheostomy Dressing 20x20cm / 8x8in OR2000 Ostomy Ring 2" Thin OR1000 Ostomy Ring 2" Standard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-10-16
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-08-28
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-10-25
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2025-08-27
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2025-08-27
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2025-08-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-10-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-10-16
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2025-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

MICHAEL ALFORD Business: Gentell LLC Email: malford@gentell.com Phone: (800) 8409041

Related Public Records

Same Entity

Casex, LTDA

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008244559. Last updated year: 2026. Please use registration number 3008244559 when referencing this establishment in official correspondence.