Wondaleaf URIFYX
A non-invasive device for managing male urinary incontinence
MDA Registration Number: GA7462924-178491
Wondaleaf® UriFYX is a free-size external male urinary catheter designed to allow visual skin inspection and to minimize the risk of penile constriction.
The device is available in three variants (R-, U-, and C-Series), allowing clinicians to choose the most suitable configuration based on patient anatomy, mobility level, and care setting.
Device Description
Wondaleaf® UriFYX is a conformable, transparent polymer sheath that fits over the penis and is secured with a medical-grade adhesive foam stabilizer. It features a silicone connector at the distal tip for attachment to standard urine drainage bags, providing a secure, non-invasive urinary management solution for male patients.
Intended Purpose
To provide a non-invasive and convenient means of managing urinary incontinence in males.
The device is designed to collect and direct urine into a drainage bag, helping to prevent accidental leakage and maintain hygiene.
Warnings
Precautions
Warnings
- Do not apply to injured or damaged skin.
- Discontinue use if redness or irritation occurs.
- Do not retract the foreskin.
Precautions
- Trim hair with clean scissors and a comb before use.
- Clean the genitalia by wiping off any moisture, dirt, or other contamination.
- Remove by peeling off the films gently and slowly.
Wondaleaf UriFYX R-Series
MDA Registration Number: GA7462924-178491
SKU: 9555864005063
A self-contained urine collection system with an integrated reservoir, designed for use with or without an external urine bag.
Adheres securely to the shaft
Integrated reservoir (capacity ≈ 400 cc)
Ideal for men who prefer a discreet, bag-free solution.
Designed for light mobility and day use
Instructional Video for UriFYX R-Series
Wondaleaf UriFYX U-Series
MDA Registration Number: GA7462924-178491
SKU: 9555864005070
Connects to standard urine bag for continuous drainage.
- Adheres securely to the glans or foreskin.
- Ideal for bedridden patients or post-surgery care.
- Support comfort and hygiene during extended use.
Instructional Video for UriFYX U-Series
Wondaleaf UriFYX C-Series
MDA Registration Number: GA7462924-178491
SKU: 9555864005087
Connects to standard urine bag for continuous drainage.
Adheres securely to the shaft.
Ideal for bedridden patients or post-surgery care.
Glans remains free from adhesive contact.
Instructional Video for UriFYX C-Series
Painless solution for urinary incontinence.
Long-lasting
Stay securely in place for up to 24 hours.
Non-invasive
No insertion into the urethra or bladder.
Transparent
Able to monitor for infection or irritation.
Free-size
Elastic and conform to different sizes.
Clinical Application Scenarios
Wondaleaf UriFYX is suitable for the following scenarios:
| Setting | Application |
|---|---|
| Hospital wards | Male incontinence, post-surgical urinary management |
| Rehabilitation units | Stroke, spinal cord injury, or limited mobility |
| Home care | Chronic incontinence management |
| Geriatric care | Elderly patients with dementia or overactive bladder |
| Palliative Care | Gentle, dignified urine drainage for end-of-life care. |
Product Specifications & Ordering Information
Our products are available on our website or through our authorized distributors. Contact us to locate a distributor in your region.
| Variants | SKU Code | Pack | Packaging |
|---|---|---|---|
| R-Series | 9555864005063 | 1 piece/pack | Box of 25 pcs |
| U-Series | 9555864005070 | 1 piece/pack | Box of 25 pcs |
| C-Series | 9555864005087 | 1 piece/pack | Box of 25 pcs |
Non-Latex • Single-Use • Keep away from sunlight
Shelf Life: 3 years
Storage: Store at room temperature in a dry area
Clinically Proven
MDA Registered
ISO Compliance
Patented
Training & Demonstration
Interested in product familiarization or staff training? Our team can provide on-site product training sessions and sample demonstrations at your facility.
Resources
Click to download the instruction for use file:
1. Biocompatibility Testing
For detailed reports on biocompatibility testing of the Wondaleaf UriFYX, please email us at admin@wondaleaf.com. Our team will be happy to provide the full documentation.
Test 1: Skin Sensitization Study (Maximization Method)
Test 2: Primary Skin Irritation Study
Test 3: Acute Systemic Toxicity Study (Systemic Injection)
2. Educational Materials
Brochure 1: Wondaleaf UriFYX (Product)
Brochure 2: Wondaleaf UriFYX U-Series
Brochure 3: Wondaleaf UriFYX R-Series
Frequently Asked Questions
For best results, we recommend shaving the application area before using Wondaleaf UriFYX. If shaving is not preferred, carefully trim the hair or use water to gently loosen the adhesive when removing the device to minimize discomfort.
As Wondaleaf UriFYX relies on adhesion, there may be some mild discomfort if it is pulled off quickly. To minimize this, gently peel away from the skin, starting from the side and removing it slowly.
Yes, Wondaleaf UriFYX can be worn for up to 24 hours on average. Replace the device according to your healthcare provider’s recommendation, typically daily or after each use.
If any part of UriFYX becomes torn or partially detached, you may trim away the loose film and reinforce it with additional strips of breathable film dressing, such as Wondaleaf Flat Dressing, to extend wear time.
Yes, Wondaleaf UriFYX is specifically designed to accommodate both circumcised and uncircumcised individuals.
Wondaleaf UriFYX is made from hypoallergenic, medical-grade materials designed to minimize the risk of irritation. With proper cleaning and skin preparation, UriFYX adheres better and stays securely in place for longer wear and comfort.
No. However, Wondaleaf UriFYX is made from flexible, medical-grade material that stretches and conforms to various sizes for a secure and comfortable fit. It also comes in three variants, each designed to suit different patient preferences and needs.
If you experience any discomfort while using Wondaleaf UriFYX, please consult your general practitioner or healthcare professional immediately.
We would also appreciate your feedback should you experience any side effects or discomfort.
Still have questions? Feel free to contact us!
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