Fushan 1/2/3 Way Balloon Urinary All Silicone Foley Urinary Drainage Urine Male PVC Nelaton Latex Urethral Catheter with CE ISO13485 and FDA
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Product Highlights
- Medical Grade Silicone: Constructed from high-quality medical grade silicone for safety and durability.
- Certified Quality: Holds CE, ISO 13485, FSC, and FDA certifications for international compliance.
- Custom Logo Printing: Logo printing can be customized to meet specific branding requirements.
- OEM/ODM Support: Full OEM and ODM services available for tailored product solutions.
- 3-Year Warranty: Comprehensive 3-year quality guarantee period for all products.
- Ethylene Oxide Sterile: Sterilized via Ethylene Oxide method, ensuring safety for adult and pediatric use.
- Flexible Packaging: Accepts both small trial orders and mass production container shipments.
- Fast Delivery: Standard delivery time ranges from 7 to 30 days based on order quantity.
Product Attributes
- Customization
- Available
- Type
- Foley Catheter
- Material
- Medical Grade Silicone
- Model NO.
- 16Fr/18Fr/20Fr/22Fr/24Fr
- Ethylene Oxide Sterilization
- Ethylene Oxide Sterilization
- Quality Guarantee Period
- 3 Years
- Group
- Adult and Children
- Logo Printing
- Can Be Customized
- Delivery Time
- 7~30 Days
- MOQ
- 1000
- Latex Free
- Yes
- Classification
- Class II
- Certificate
- CE, ISO13485, FSC
- Free Sample
- Available
- Balloon Volume
- 15cc/30cc
- OEM
- Avaliable
- ODM
- Avaliable
- Sterile
- Eo
- Business Type
- Manufacture
- Package
- Paper-Poly Bag
- Port of Loading
- Shanghai
- Trade Terms
- Fob Shanghai
- Lumen
- 3-Way
- Transport Package
- Corrugated Carton
- Specification
- 16Fr~24Fr
- Trademark
- FUSHAN or OEM brand
- Origin
- Zhejiang, China
- HS Code
- 90183900
- Production Capacity
- 80000 Piece/Pieces Per Month
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Product Description
In urology, a Foley catheter (named for Frederic Foley, who produced the original design in 1929) is a flexible tube that a clinician passes through the urethra and into the bladder to drain urine. It is the most common type of indwelling urinary catheter.
The tube has two separated channels, or lumens, running down its length. One lumen, open at both ends, drains urine into a collection bag. The other has a valve on the outside end and connects to a balloon at the inside tip. The balloon is inflated with sterile water when it lies inside the bladder to stop it from slipping out. Manufacturers usually produce Foley catheters using silicone or coated natural latex.
Foley catheters should be used only when indicated, as use increases the risk of catheter-associated urinary tract infection and other adverse effects.
| Product No. | Size(Fr) | Color Code | Balloon Volume(ml) | Remark |
| FC1615S3 | 16 | Orange | 5-15ml | Without Stylet |
| FC1815S3 | 18 | Red | ||
| FC2015S3 | 20 | Yellow | ||
| FC2215S3 | 22 | Purple | ||
| FC2415S3 | 24 | Blue | ||
| FC1630S3 | 16 | Orange | 30ml | |
| FC1830S3 | 18 | Red | ||
| FC2030S3 | 20 | Yellow | ||
| FC2230S3 | 22 | Purple | ||
| FC2430S3 | 24 | Blue |









Q: What kind of certificate do you have?
A: We are a professional manufacturer and we have CE, ISO 13485, FSC and other certificate for internatial business.Q: Where is your factory? How can I visit there?
A: Our factory locates in Lin'an District, Hangzhou City, Zhejiang Province, China. It takes 3 hours to travel from Shanghai airport or 1.5 hours from Hangzhou East Railway Station to drive here. We can pick you up if you need, welcome to visit our factory.
Q: What is the regular package of your products?
A: Our regular inner package is a blank paper-plastic bag. OEM printing package is also available.
Q: Can you provide samples?
A: We can provide samples as per your request. Please feel free to contact us for further details.
Q: How do you do to control the quality of your products?
A: We believe that quality is the key to win credibility. Our QMS is strictly controlled according to ISO 13485 standards.
Q: How do you send the goods to us?
A: For mass quantity orders, we will send the goods by containers or trains. For small orders or trial order, we will choose air shipment or international express.
Q: How can I get a price?
A: We would like to offer you a stepwise quotation list based on your inquiry. If you can provide more specified details, we will offer more accurate prices.
Q: Can you provide OEM service?
A: Sure, we can provide OEM & ODM service.
Q: I am a wholesaler, do you accept small order?
A: Yes, either small order or trial order is acceptable. We would like to extend our business with you together.
Q: What is the lead time for the mass production?
A: Our lead time depends on the order quantity and the season when you place the order, generally speaking it takes about 20-35 working days.
About the Supplier
This supplier has been audited by SGS. Verify the report on the official SGS website with ID "QIP-ASI223975". Items marked "" are certified.
Company Profile
Hangzhou Fushan Medical Appliances Co., Ltd. Was established in July 2005. It locates at Lin'an Linglong Industrial Park in the west of Hangzhou.
The factory of Fushan Medical covers an area of over 13, 000 sqms. Both class 10, 000 and class 100, 000 clean workshops are designed and constructed according to GMP standards. With various precise manufacture and inspection facilities, Fushan provides different kinds of medical devices by silicone, polyurethane (PU) and polyvinyl chloride (PVC).
Meanwhile, Fushan designed and built professional labs for sterile, physicochemical and electrical tests. It also equipped with CE verified ETO sterilization chambers. Sterilization verification report can be issued as request.
Fushan manufactures and sells various kinds of products, which refers to anesthesia series, gastroenterology series, surgical drainage series, urology and gynecology series etc. All products are granted with CE certificate, and most of them are registered in FDA. Fushan also provides OEM/ODM service to the market.
With the philosophy of "standard, preciseness, concertration and innovation", Fushan is always keeping providing high grade medical devices to the world.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- No. 1288, South Jinxi Road, Linglong Industrial Park, Lin'an District, Hangzhou, Zhejiang, China
-
Plant Area
- 13,753 square meters
-
Number of Employees
- 260
-
Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR
-
Average Lead Time
-
Peak Season Lead Time: one month
Off Season Lead Time: one month -
Nearest Port
- Ningbo Port, Shanghai Port
Our Production Capability & Technical Expertise
-
Main Products
- Silicone Stomach Tube, Silicone Nasogastric Tube, Silicone Gastrostomy Tube, PEG Kit, Laryngeal Mask, Endotracheal Tube, Silicone Drainage Tube, Silicone Drainage Kit, Silicone Reservoir, Silicone Foley Catheter, CVC, Needle Free Connector
-
Production Machines
- Rubber Mixing Machine, Extruding Machine, Cutting Machine, Printing Machine, Drying Machine, Injection Machine, Molding Machine, Sterilization Workshop, Abrasion Wear Test Machine, Rigidity Tester, Toughness Tester, Puncture Force Tester, Overhead Projector, Material Testing Machine, Meteorological Chromatograph, Total Organic Carbon Analyzer, Hydraulic Molding Machine, Autoclave, Water Bath Kettle, Biosafety Cabinet
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 17 people
-
Own Brand
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2005-07-06
- Export Year
- 2008-11-01
-
Main Markets
- North America, South America, Europe, Southeast Asia/ Mideast, Africa, East Asia(Japan/ South Korea), Australia, Domestic
-
Number of Foreign Trading Staff
- 17
-
Overseas Agent/Branch
- No
Our Certifications, Standards & Industry Recognition
-
Product Certification
- CE
FAQ
- What certifications does the product have?
- We have CE, ISO 13485, FSC, and FDA certificates for international business.
- Where is your factory located?
- Our factory is in Lin'an District, Hangzhou City, Zhejiang Province, China. It takes 3 hours from Shanghai airport or 1.5 hours from Hangzhou East Railway Station.
- What is the standard packaging?
- The regular inner package is a blank paper-plastic bag. OEM printing packages are also available.
- Can you provide free samples?
- Yes, we can provide samples as per your request. Please contact us for further details.
- How do you control product quality?
- Our QMS is strictly controlled according to ISO 13485 standards to ensure quality and credibility.
- What are the shipping methods?
- Mass orders are sent by containers or trains. Small or trial orders are sent by air shipment or international express.
- Do you accept small orders?
- Yes, we accept both small orders and trial orders to extend our business partnership.
- What is the lead time for mass production?
- Lead time depends on order quantity and season, generally taking about 20-35 working days.
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