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Sign in to claim this brandLaborie Medical Technologies Canada ULC
US
Last updated May 27, 2026
What Laborie Medical Technologies Canada ULC makes
Laborie Medical Technologies Canada ULC manufactures urodynamic assessment tools, including non-electronic manometric catheters, reusable and single-use pressure monitoring tubing sets, and reusable urine flowmeters. Their portfolio also includes electrically-powered arthroscopic shaver systems, air/gas pressure transducers, and urodynamic measurement systems for bladder function evaluation. Additionally, they produce infusion pump administration sets and general-purpose ultrasound imaging systems for diagnostic imaging.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable medical device compliance standards for these categories.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- laborie.com
- —
- —
- [email protected]
- Phone
- +1(800)522-8743
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 203383526
Catalogue (291)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Air-Charged Reusable Cable | CAB4550P4 | FDA UDI | Class II | Active |
| Abdominal Pressure Catheter 9F | ERPC-9 | FDA UDI | Class II | Active |
| Perfusion Set 8 | 9021P6082 | FDA UDI | Class II | Active |
| Bubble Detector | TRA1001 | FDA UDI | Class II | Active |
| Tubing, Infusion Pump for MMS Solar Systems | TUBPTMS | FDA UDI | Class II | Active |
| NXT Go Urodynamics System | NXT2100 | FDA UDI | Class II | Active |
| Air-Charged Reusable Cable | CAB580 | FDA UDI | Class II | Active |
| Triton | CAR820 | FDA UDI | Class II | Active |
| Catheter, Pves, Pura & Vinf, Triple Lumen, Radiopaque, Male, 7Fr | CATW1B37EMX | FDA UDI | Class II | Active |
| Triton | CAR821 | FDA UDI | Class II | Active |
| Tubing, Extension Line, Yellow for Pura, 150 cm | TUBEX1Y | FDA UDI | Class II | Active |
| Aquarius TT | PRO176 | FDA UDI | Class II | Active |
| Air-Charged Reusable Cable | CAB670 | FDA UDI | Class II | Active |
| Catheter, Pabd, Single Lumen, Split Balloon, PVC , Introducer 4.5Fr | CATW1A15ESI | FDA UDI | Class II | Active |
| 1-lumen Catheter | 9021P1063 | FDA UDI | Class II | Active |
| NuWav | PRB250 | FDA UDI | Class II | Active |
| Dual Infusion Pump Tube Set | DIPTS-LT2 | FDA UDI | Class II | Active |
| Tubing, Infusion Pump for Mediwatch Systems | TUBPTMDW | FDA UDI | Class II | Active |
| Catheter, Pabd, Single Lumen, Split Balloon, PVC, 4.5Fr | CATW1A15ES | FDA UDI | Class II | Active |
| Dual Lumen Catheter 6F | DLC-6D | FDA UDI | Class II | Active |
| Extension Line, 15cm | 9021P6351 | FDA UDI | Class II | Active |
| SondeAR - Air Charged Catheter | SAR-PC | FDA UDI | Class II | Active |
| Tube for Anal Sensor, with 3-way Stopcock | PRB078 | FDA UDI | Class II | Active |
| 2-lumen Catheter for Cystometry 10 Fr. (400 mm) | 9021P5302 | EUDAMEDFDA UDI | Class II | Active |
| Aquarius XT | AQS3001 | EUDAMEDFDA UDI | Class II | Active |
| Roam NXT | ROX2001 | FDA UDI | Class II | Active |
| Dorado KT Cart with Evox (240V) | Dorado KT with EVOX | FDA UDI | Class II | Active |
| Catheter, Pabd, Dual Lumen, Closed Balloon, Silicone, 9Fr | CATW1A29EB | FDA UDI | Class II | Active |
| Triple Lumen Catheter 7F Female | TLC-7F | FDA UDI | Class II | Active |
| Tubing, Infusion Pump for MMS Solar Systems, with spikes | TUBPTMS2 | FDA UDI | Class II | Active |
| Tubing, Infusion Pump for MMS Nexam NPU Systems | TUBPTMN | FDA UDI | Class II | Active |
| 2-Way Stop Cock | 2-SC | FDA UDI | Class II | Active |
| Pump Hub | PMP1000 | FDA UDI | Class II | Active |
| Bladder filling Catheter | 9021P5210 | FDA UDI | Class II | Active |
| Wire Electrode Needle Set Male | 1512A-F | FDA UDI | Class II | Active |
| 8 Ch. Single Use Anorectal Manometry Catheter-Radi | 9012P1312 | FDA UDI | Class II | Active |
| 3-lumen Catheter for Cystometry and UPP | 9021P5803A | FDA UDI | Class II | Active |
| Perfusion Set 1 | 9021P6012 | FDA UDI | Class II | Active |
| Peritron | PRN09301 | FDA UDI | Class II | Active |
| Catheter, Pves & Vinf, Dual Lumen, Tiemann Tip, 8Fr | CATW1B28ET | FDA UDI | Class II | Active |
| Dorado KT | Dorado KT | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Laborie Medical Technologies Canada ULC has one recall record initiated on 2020-04-22, which is listed with a terminated status. The recall was prompted by a field correction to address potentially damaged seals in the packaging of some Pump Tube Sets, where inventory was found to have breaches or folds in the seals.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 22, 2020 | Z-2535-2020 | — | terminated | This field correction is being initiated to address potentially damaged seals in the packaging of some the Laborie Pump Tube Sets. Finished goods inventory was detected with damage to their seals in the form of breaches or folds. Based on our investigation the issue appears to be limited to a single lot of part number 902101226 pump tubing sets. |