FDA Registration
Active
🇧🇷 Brazil
CASEX, LTDA
Reg #: 3008244559
·
FEI: 3008244559
·
Expires 2026
Products
10
Proprietary Names
75
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- CASEX, LTDA
- Registration Number
- 3008244559
- FEI Number
- 3008244559
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Av. Fredolin Wolf, 4474
- City
- Curitiba Parana
- Country
- BR
Owner / Operator
- Firm Name
- Casex, LTDA
- Operator Number
- 10046440
- Address
- Av. Fredolin Wolf, 4474
- City
- Curitiba
- State
- Parana
- Postal Code
- 82410
- Country
- BR
US Agent
- Business Name
- Gentell LLC
- Contact Name
- MICHAEL ALFORD
- Address
- 1000 Floral Vale Blvd Ste 400
- City
- Morrisville
- State
- PA
- ZIP
- 19067
- Country
- US
- [email protected]
- Phone
- 800 8409041
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Stomal Appliance, Ostomy | EZR | Class 1 | Gastroenterology, Urology | No | 2020-10-16 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-08-28 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2020-10-25 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 2025-08-27 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2025-08-27 |
| Bag, Urinary, Ileostomy | EXH | Class 1 | Gastroenterology, Urology | No | 2025-08-27 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2020-10-16 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2020-10-16 |
| Appliance, Colostomy, Disposable | EZS | Class 1 | Gastroenterology, Urology | No | 2025-08-27 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2021-08-03 |
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
2700-70C Closed-end 2 pouch pieces clear 70mm
2700-57W Closed-end 2 pouch pieces opaque 57mm
2700-57C Closed-end 2 pouch pieces clear 57mm
3700-45C Closed-end 2 pouch pieces clear 45mm
3700-45W Closed-end 2 pouch pieces opaque 45mm
3700-57W Closed-end 2 pouch pieces opaque 57mm
2245-00C Closed-end pouch adhesive 1 piece clear 13/64mm
2250-00W Closed-end pouch without adhesive 1 piece opaque 13/64mm
2250-00C Closed-end pouch without adhesive 1 piece clear 13/64mm
2700-70C Closed-end 2 pouch pieces clear 70mm
2700-70W Closed-end 2 pouch pieces opaque 70mm
3700-57C Closed-end 2 pouch pieces clear 57mm
2700-45W Closed-end 2 pouch pieces opaque 45mm
3700-70W Closed-end 2 pouch pieces opaque 70mm
2700-45C Closed-end 2 pouch pieces clear 45mm
2245-00W Closed-end pouch adhesive 1 piece opaque 13/64mm
Establishment Types
Manufacture Medical Device