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Laborie Medical Technologies Canada ULC

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)522-8743
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 203383526

Catalogue (290)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
Catheter, Pura & Pves, Dual Lumen, Coaxial Design, 8Fr	CATW1U28EK	FDA UDI	Class II	Active
SondeAR - Air Charged Catheter	SAR-AC	FDA UDI	Class II	Active
Catheter, Pves & Vinf, Dual Lumen, 8Fr	CATW1B28E	FDA UDI	Class II	Active
Urocap IV	TRA851	FDA UDI	Class II	Active
Pump Guard / Dampening chamber	TUBDC	FDA UDI	Class II	Active
Extension Line, 150cm Blue	9021P6371	FDA UDI	Class II	Active
Catheter, Pves & Vinf, Dual Lumen, Pigtail, 6Fr	CATW1B26EP	FDA UDI	Class II	Active
Bladder filling Catheter	9021P5220	FDA UDI	Class II	Active
2-lumen Catheter for Abdominal Pressure	9021P4642	FDA UDI	Class II	Active
Bladder filling Catheter	9021P5230	FDA UDI	Class II	Active
Peritron+	PRN04000	FDA UDI	Class II	Active
1-lumen Catheter	9021P1093	FDA UDI	Class II	Active
Ptta-C	PTTA-C	FDA UDI	Class II	Active
Tubing, Infusion Pump for MMS Solar Systems, with chamber	TUBPTMSP	FDA UDI	Class II	Active
Extension Line, 90 cm	9021P6322	FDA UDI	Class II	Active
Tub576	TUB576	FDA UDI	Class II	Active
4 Ch. Single Use Anorectal Manometry Catheter-Radi	9012P1392	FDA UDI	Class II	Active
Infusion set for Cavernosometry	9021O1184	FDA UDI	Class II	Active
Abdominal Pressure Catheter 9F	RPC-9	FDA UDI	Class II	Active
Pump Tubing Infusion Line	TUB500	FDA UDI	Class II	Active
Probe, Manometry, Anal Sensor	PRB108	FDA UDI	Class II	Active
Female Catheter Pack	5138P0011	FDA UDI	Class II	Active
Cystometry Pack	9021T1051	FDA UDI	Class II	Active
Pump Guard	9021O1291	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4060P4	FDA UDI	Class II	Active
Goby	GBS006	FDA UDI	Class II	Active
All Purpose Infusion Set	APIS	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB707	FDA UDI	Class II	Active
Aquarius CTS	AQS2004	FDA UDI	Class II	Active
injeTAK Adjustable Tip Needle 35cm	DIS199	FDA UDI	Class II	Active
Bladder Pressure Catheter	9021P0900	FDA UDI	Class II	Active
Perfusion Set 4	9021P6042	FDA UDI	Class II	Active
Cystometry Pack	9021T1021	FDA UDI	Class II	Active
PIM NXT for Fluid	PIX2231	FDA UDI	Class II	Active
NuWav	PRB240	FDA UDI	Class II	Active
Aquarius XT	AQS3002	FDA UDI	Class II	Active
Ptta-R	PTTA-R	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry 6 Fr. (400 mm)	9021P5662	FDA UDI	Class II	Active
Pump Tube Set	9021O1206	FDA UDI	Class II	Active
Pressure Transmission Tubing	PTTA-B	FDA UDI	Class II	Active
Voiding Adapter	5138H0011	FDA UDI	Class II	Active
Pump Tube Set	400120014	FDA UDI	Class II	Active
1880 Interchangeable Pressure Transducer	1880	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4023A	FDA UDI	Class II	Active
Tubing, Extension Line, Clear, with Stopcock, 150 cm	TUBEX1CS	FDA UDI	Class II	Active
Catheter, Pves & Vinf, Dual Lumen, Coude Tip, 5Fr	CATW1B25EC	FDA UDI	Class II	Active
Aquarius TT	CAR830	FDA UDI	Class II	Active
Catheter, Pura & Pves, Dual Lumen, 8Fr	CATW1U28E	FDA UDI	Class II	Active
Dorado KT Cart with Evox (120V)	Dorado KT with EVOX	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB788	FDA UDI	Class II	Active

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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.