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Sign in to claim this brandWellspect AB
US
Last updated May 24, 2026
What Wellspect AB makes
The company manufactures single-use and reusable devices for urinary and rectal care, including urethral catheterization kits, drainage catheters, and irrigation systems. Products include manual and powered rectal/colostomy irrigation systems, urethral dilatation catheters, and consumable sets for intermittent drainage. Some devices incorporate hydrophilic technology for reduced friction during insertion.
These products are classified under FDA regulations as Class I and Class II devices, with some authorised via the 510(k) pathway and others under the UDI (Unique Device Identification) system. The company’s devices are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Wellspect AB manufacture?
Wellspect AB produces devices primarily for urinary and rectal care. Their portfolio includes single-use and reusable items like urethral catheterization kits, single-administration and intermittent urethral drainage catheters, manual and powered rectal/colostomy irrigation systems, and urethral dilatation catheters. Some products, such as the GentleCath Hydrophilic Kit, use hydrophilic technology to minimize friction during insertion, improving patient comfort.
Where is Wellspect AB based, and what does that mean for their regulatory oversight?
Wellspect AB is based in the United States, which means their devices fall under FDA regulatory jurisdiction. Since the company’s products are classified as Class I or Class II devices, they must comply with FDA requirements for safety and performance. The FDA lists these devices in its databases, such as the 510(k) premarket notification system or the Unique Device Identification (UDI) system, depending on the device type and classification.
How are Wellspect AB’s devices classified under FDA regulations, and why does this matter?
Wellspect AB’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may require special controls or performance standards. This classification determines the regulatory pathway—such as 510(k) clearance for Class II or UDI registration for both classes—to ensure compliance with safety and effectiveness requirements before they enter the market.
Which regulatory databases list Wellspect AB’s devices, and how can I verify their status?
Wellspect AB’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process for certain Class II devices or the Unique Device Identification (UDI) system for broader tracking. To verify a specific device’s status, you can search the FDA’s public databases like the 510(k) database or the UDI database using the device’s name or identification number. These records confirm whether the device has undergone the necessary regulatory review.
What distinguishes Wellspect AB’s catheter and irrigation systems from other similar products?
Wellspect AB’s devices often incorporate specialized features like hydrophilic coatings (e.g., in the GentleCath Hydrophilic Kit) to reduce friction during insertion, enhancing patient comfort. Their product line also includes both manual and powered systems for rectal/colostomy irrigation, catering to different clinical needs. The company’s offerings span single-use and reusable options, ensuring flexibility for healthcare providers while maintaining compliance with FDA classification standards for safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- wellspect.com
- —
- —
- [email protected]
- Phone
- +1(877)456-3742
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 351118942
Catalogue (409)
Page 1 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LoFric® Primo™ | 41308 | FDA UDI | Class II | Unknown |
| SimPro™ Core | 5431000 | FDA UDI | Class II | Unknown |
| GentleCath Hydrophilic Kit | 509005 | FDA UDI | Class II | Active |
| LoFric® Hydro-Kit™ | 42318 | FDA UDI | Class II | Unknown |
| Navina™ Classic System Regular | 69005 | FDA UDI | Class II | Active |
| Navina™Consumable Set Cone | 69016 | FDA UDI | Class I | Active |
| Navina™ Smart control unit with power adapter and cable | 69014 | FDA UDI | Class II | Unknown |
| SimPro™ Now | 5151000 | FDA UDI | Class II | Unknown |
| SimPro™ Core | 5430800 | FDA UDI | Class II | Unknown |
| SimPro™ Now | 5121000 | FDA UDI | Class II | Unknown |
| SimPro™ Now | 5131400 | FDA UDI | Class II | Active |
| SimPro™ Set | 5351600 | FDA UDI | Class I | Active |
| LoFric® Origo™ | 44310 | FDA UDI | Class II | Unknown |
| SimPro™ Now | 5152000 | FDA UDI | Class II | Unknown |
| SimPro™ Now | 5151600 | FDA UDI | Class II | Active |
| LoFric® Elle™ | 4181450 | FDA UDI | Class II | Active |
| LoFric® Primo™ | 41106 | FDA UDI | Class II | Unknown |
| GentleCath Hydrophilic Kit | 509009 | FDA UDI | Class I | Active |
| LoFric® Hydro-Kit™ | 42014 | FDA UDI | Class II | Active |
| LoFric® Origo™ | 44716 | FDA UDI | Class II | Active |
| LoFric® Sense™ | 4161050 | FDA UDI | Class II | Active |
| GentleCath Hydrophilic Kit | 509006 | FDA UDI | Class II | Active |
| LoFric® Origo™ | 44416 | FDA UDI | Class II | Active |
| SimPro™ Now | 5151800 | FDA UDI | Class II | Unknown |
| LoFric® Elle™ | 4181225 | FDA UDI | Class II | Unknown |
| LoFric® Hydro-Kit™ | 42510 | FDA UDI | Class II | Unknown |
| Dila-Cath Nelaton 40cm CH18 | 40618 | FDA UDI | Class I | Unknown |
| LoFric® Primo™ | 41514 | FDA UDI | Class II | Unknown |
| LoFric® Hydro-Kit™ | 42108 | FDA UDI | Class II | Active |
| LoFric® Hydro-Kit™ | 42016 | FDA UDI | Class II | Unknown |
| LoFric® Sense™ | 4161025 | FDA UDI | Class II | Unknown |
| SimPro™ Core | 5401600 | FDA UDI | Class II | Unknown |
| SimPro™ Set | 5351000 | FDA UDI | Class II | Active |
| SimPro™ Now | 5141000 | FDA UDI | Class II | Unknown |
| SimPro™ Set | 5301200 | FDA UDI | Class I | Active |
| LoFric® Origo™ | 44512 | FDA UDI | Class II | Unknown |
| LoFric® Hydro-Kit™ | 42308 | FDA UDI | Class II | Unknown |
| SimPro™ Set | 5331200 | FDA UDI | Class II | Active |
| LoFric® | 40014 | FDA UDI | Class II | Unknown |
| SimPro™ Now | 5151000 | FDA UDI | Class II | Active |
| Navina™ Catheter Set Small | 68943 | FDA UDI | Class I | Active |
| GentleCath Hydrophilic | 508998 | FDA UDI | Class II | Active |
| LoFric® Hydro-Kit™ | 42014 | FDA UDI | Class II | Unknown |
| GentleCath Hydrophilic Kit | 509016 | FDA UDI | Class II | Active |
| GentleCath Hydrophilic | 508992 | FDA UDI | Class II | Active |
| Navina Mini Extension Set | 6930840 | FDA UDI | Class I | Active |
| LoFric® Hydro-Kit™ | 42516 | FDA UDI | Class II | Active |
| GentleCath Hydrophilic | 508990 | FDA UDI | Class II | Active |
| Navina™ Smart System Regular | 69009 | FDA UDI | Class I | Unknown |
| LoFric® Hydro-Kit™ | 42310 | FDA UDI | Class II | Active |
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