Data / Medical devices / Sweden / Wellspect Healthcare
Wellspect Healthcare: FDA-registered device maker in Molndal Vastra Gotaland, Sweden, 9 510(k) clearances
Wellspect Healthcare is registered with the FDA (registration 3009632672) in Molndal Vastra Gotaland, Sweden. It lists 12 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 17, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009632672
- Address
- Aminogatan 1, Molndal Vastra Gotaland, Sweden, SE-43121
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Contract sterilizer, Manufacturer, Specification developer
- First device listed
- October 23, 2001
- Registered through
- 2027
- Brand names listed
- Implant, PrimeTaper, catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract sterilizer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract sterilizer | accessdata.fda.gov |
| Catheter, Coude | EZC | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Straight | EZD | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | 1 | Specification developer | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hearing Aid, Bone Conduction | LXB | 2 | Contract sterilizer | accessdata.fda.gov |
| Hearing Aid, Bone Conduction, Implanted | MAH | 2 | Contract sterilizer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract sterilizer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Sound, Urethral, Metal Or Plastic | FBX | 1 | Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2026 | K261658 | LoFric Origo Pro Coudé | EZD | Substantially Equivalent | Wellspect AB | accessdata.fda.gov |
| April 24, 2026 | K260999 | LoFric Elle Pro | EZD | Substantially Equivalent | Wellspect AB | accessdata.fda.gov |
| September 26, 2025 | K250659 | LoFric Origo | EZD | Substantially Equivalent | Wellspect AB | accessdata.fda.gov |
| May 4, 2023 | K223756 | SimPro Now, GentleCath Hydrophilic | EZD | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| February 17, 2022 | K211212 | LoFric Elle | EZD | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| November 22, 2019 | K190977 | Navina Smart System, Navina Classic System | KNT | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| February 28, 2013 | K123751 | LOFRIC SENSE | EZD | Substantially Equivalent | Wellspect Healthcare | accessdata.fda.gov |
| October 31, 2012 | K122078 | LOFRIC PRIMO, LOFRIC HYDRO-KIT | EZD | Substantially Equivalent | Astra Tech, Inc. | accessdata.fda.gov |
| April 17, 2012 | K113424 | LOFRIC SINGLE USE URINARY CATHETER | EZD | Substantially Equivalent | Astra Tech AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 17, 2020 | 85905 | Class II | Terminated | LoFric Origo, Nelaton, 16in, FR10 urinary catheters | Wellspect Healthcare is voluntarily recalling certain LoFric Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Enema Kit
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Hearing Aid, Bone Conduction
- All makers of Catheter, Coude
Updated July 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.