Balloon tested to 3x nominal inflation volume without rupture. Every catheter individually EO sterilized. Batch traceability to raw material level.
EKINSUN manufactures a complete Foley urinary catheter range for hospitals, distributors, and OEM medical device brands. Three product lines: standard 2-way drainage, 3-way irrigation for post-surgical bladder washout, and pediatric temperature-sensing with integrated NTC thermistor for continuous PICU core temperature monitoring. All EO sterilized, individually packed, CE marked.
| Types | 2-way · 3-way · Pediatric temperature (3 lines) |
| French size range | 6Fr – 30Fr (see stock sizes below) |
| Material options | 100% Silicone (long-term) · Silicone-coated Latex (short-term) |
| Balloon capacity | 3ml · 5ml · 10ml · 30ml · custom |
| Balloon test | 3x nominal volume without rupture |
| Tip styles | Round · Tiemann (coude) · Couvelaire |
| Drainage eyes | 2 or 4 (specify) |
| Pediatric temp sizes | 6Fr · 8Fr · 10Fr · 12Fr with NTC sensor |
| Temp accuracy | ±0.1°C over 25°C – 42°C range |
| Temp connector | 2-pin NTC (standard patient monitor interface) |
| Sterilization | EO sterile · SAL 10⁻⁶ · single-use |
| Shelf life | 5 years from sterilization date |
| Certification | CE · ISO 13485 · ISO 10555 |
| Stock lead time | 7–10 business days |
| Custom lead time | 30–45 days from approved spec |
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Clinical Applications by Catheter Type
2-Way Foley Catheter — Standard Urinary Drainage
The 2-way Foley catheter is the most commonly used urinary catheter in acute hospital care. Indications include pre- and post-operative urinary drainage, urinary retention, accurate urine output monitoring in critically ill patients, and long-term urinary drainage for patients with neurogenic bladder or mobility limitations. The 5ml or 10ml balloon holds the catheter in the bladder after insertion. Selection guide: 14Fr–16Fr for standard adult female patients, 16Fr–18Fr for standard adult male patients, 20Fr–24Fr for post-TURP large-lumen drainage, 6Fr–12Fr for pediatric patients.
3-Way Foley Catheter — Bladder Irrigation
The 3-way catheter adds a third lumen dedicated to continuous bladder irrigation (CBI), allowing saline to flow in while urine and irrigant drain out simultaneously — essential for clearing blood clots after transurethral resection of the prostate (TURP), bladder tumor resection, or any procedure with significant intravesical bleeding. The irrigation lumen is typically larger-bore than the drainage lumen to allow high-flow saline input. Common sizes: 22Fr–26Fr for post-TURP, 18Fr–22Fr for other post-surgical irrigation. A 30ml balloon is standard for post-TURP use to provide tamponade pressure against the prostatic fossa.
Pediatric Temperature-Sensing Foley Catheter
Designed for neonatal and pediatric ICU (PICU/NICU) use where continuous core temperature monitoring alongside urinary output measurement is needed. An NTC (negative temperature coefficient) thermistor is embedded in the catheter tip — as the catheter sits in the bladder, it measures intravesical temperature, which closely tracks core body temperature. This eliminates the need for a separate rectal temperature probe, reducing infection risk and discomfort. The 2-pin NTC output is compatible with standard bedside monitor temperature input modules from Philips, GE, Draeger, and Mindray. Available in 6Fr, 8Fr, 10Fr, and 12Fr.
Material Comparison — 100% Silicone vs Silicone-Coated Latex
| Property | 100% Silicone | Silicone-Coated Latex |
|---|---|---|
| Max indwelling duration | Up to 12 weeks | Up to 7 days |
| Latex allergy risk | None — latex-free | Contains latex — contraindicated |
| Softness / flexibility | Softer, more flexible | Slightly firmer |
| Encrustation resistance | Superior | Moderate |
| Biocompatibility | Excellent (ISO 10993) | Good |
| Cost | Higher | Lower |
| Best use case | Long-term, home care, latex allergy | Acute post-op, short ICU stay |
Balloon Volume Selection Guide
| Balloon Volume | Clinical Indication | Typical Fr Size |
|---|---|---|
| 3ml | Pediatric and neonatal use | 6Fr – 12Fr |
| 5ml | Standard adult — general drainage | 14Fr – 20Fr |
| 10ml | Standard adult — alternative, more secure retention | 14Fr – 22Fr |
| 30ml | Post-TURP tamponade, obstetric PPH adjunct | 22Fr – 26Fr |
Tip Style Selection Guide
| Tip Style | Description | Indication |
|---|---|---|
| Round (Standard) | Straight, rounded atraumatic tip | Standard catheterization, most patients |
| Tiemann (Coude) | Upward-angled curved tip | Benign prostatic hyperplasia (BPH), urethral stricture |
| Couvelaire | Open-ended tip, multiple eyes | Post-TURP — allows clot drainage without blockage |
Quality & Manufacturing Standards
All Foley catheters are manufactured in our ISO 13485-certified facility in Guangdong, China. Key quality control steps include:
- Balloon integrity test: every balloon inflated to 3x nominal volume and inspected for rupture or leak before assembly
- Lumen patency check: all drainage and irrigation lumens flow-tested on 100% of units
- Dimensional verification: Fr size, balloon position, and total catheter length checked per batch against ISO 10555 dimensional requirements
- Biocompatibility: ISO 10993 testing including cytotoxicity, sensitization, and intracutaneous reactivity — certificates available in technical file
- EO sterilization: validated SAL 10⁻⁶ with EO residual testing per ISO 10993-7 before release
Also see our silicone veterinary urinary catheters (3.5Fr, 4.5Fr, 6Fr) for animal clinic and veterinary distributor applications, and our cervical and uterine balloon catheters for obstetric and gynecological applications.
OEM Private Label for Distributors
EKINSUN is an established OEM supplier for medical distributors and device brands in Europe, the Middle East, Southeast Asia, and Latin America. Our standard OEM service for Foley catheters includes:
- SKU definition — specify type (2-way/3-way/temp), Fr sizes, material, balloon volume, tip style
- Label artwork — we design from brief or work from your supplied artwork (PDF, AI, EPS)
- Regulatory documentation — CE DoC, ISO 13485 cert, EO cert, CoA per batch, under your product name
- Minimum order — 500 pcs per SKU for peel-pack label; 1000 pcs for carton printing
- Languages supported — English, Spanish, German, French, Arabic, Portuguese IFU inserts
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Frequently Asked Questions
A 2-way Foley catheter has two lumens: one for urine drainage and one for balloon inflation. It is used for standard urinary drainage in acute and post-operative settings. A 3-way Foley catheter adds a third lumen for continuous bladder irrigation (CBI) — used after transurethral resection of the prostate (TURP), cystoscopy, or bladder surgery where blood clot irrigation is required. We supply both in the same Fr size range.
We stock 6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr in both 2-way and 3-way silicone-coated latex. 100% silicone is stocked in 12Fr–24Fr. Pediatric temperature-sensing catheters are stocked in 6Fr, 8Fr, 10Fr, and 12Fr. Non-standard sizes available at 1000 pcs MOQ.
100% silicone is recommended for long-term catheterization exceeding 7 days (rated up to 12 weeks), latex-allergic patients, and patients with silicone gel implants or hypersensitivity. Silicone-coated latex is appropriate for short-term catheterization (up to 7 days) and is more cost-effective for high-volume acute care settings. Silicone catheters are softer and more flexible than latex at equivalent Fr size, which can improve patient comfort during long-term use.
An NTC thermistor sensor is embedded in the catheter tip and measures intravesical (bladder) temperature, which closely correlates with core body temperature. The sensor output connects to a standard patient monitor via a 2-pin NTC connector. Accuracy is plus or minus 0.1 degrees Celsius over a range of 25 to 42 degrees Celsius. This eliminates the need for a rectal temperature probe in PICU patients, reducing infection risk and improving patient comfort during continuous temperature monitoring.
Standard balloon volumes: 3ml (pediatric and neonatal), 5ml (standard adult), 10ml (standard adult alternative), 30ml (post-partum or hemorrhage control). Custom volumes (15ml, 50ml) available at 1000 pcs MOQ. Balloon is tested to 3x nominal inflation volume without rupture. One-way inflation valve prevents inadvertent deflation.
Round tip (standard, atraumatic), Tiemann tip (coude, angled — for benign prostatic hyperplasia and urethral stricture), and Couvelaire tip (open-ended, for post-TURP drainage of blood clots). Specify tip style at inquiry. Tiemann and Couvelaire are stock items in common Fr sizes.
Yes. We can supply complete urinary drainage kits including Foley catheter, drainage bag (500ml or 2000ml), and urethral gel sachet. Kit assembly and co-packing available. Specify kit configuration at inquiry.
500 pcs per SKU (size and type combination) for standard OEM with your custom peel-pack label. 1000 pcs for outer carton printing. Multilingual IFU insert (English, Spanish, German, French, Arabic) available. CE documentation supplied under your product registration.
100% silicone catheters contain no latex and are suitable for latex-allergic patients. Silicone-coated latex catheters do contain latex in the core and are not suitable for patients with latex allergy (Type I hypersensitivity). Always check patient latex allergy status before selecting catheter type.
5 years from EO sterilization date for both silicone and latex versions, when stored below 30 degrees Celsius and away from direct sunlight and ozone sources. Latex catheters should be stored away from electrical equipment that generates ozone, which degrades rubber over time.
Yes. We accept client drawings, ISO standard references, or physical samples as design input. Custom Fr sizes, lumen configurations, balloon volumes, tip shapes, and color coding are all feasible. NDA signed before receiving any proprietary specifications. First article sample and dimensional report supplied before production commitment.
CE declaration of conformity under EU MDR 2017/745, ISO 13485 manufacturing certificate, ISO 10555 catheter test report, EO sterilization validation certificate, and batch certificate of analysis. Biocompatibility data per ISO 10993 (cytotoxicity, sensitization, intracutaneous reactivity) available in the technical file under NDA.