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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 (291)

Page 2 of 6

Device	Model / Reference	Registries	Class	Status
Catheter, Pves, Pura & Vinf, Triple Lumen, 9Fr	CATW1B39E	FDA UDI	Class II	Active
Abdominal Pressure Catheter 9F	RPC-9	FDA UDI	Class II	Active
Urocap IV Light	UCL2000	FDA UDI	Class II	Active
Catheter, Pves, Pura & Vinf, Triple Lumen, Radiopaque, Female, 7Fr	CATW1B37EFX	FDA UDI	Class II	Active
Aquarius CT	AQS2001	EUDAMEDFDA UDI	Class II	Active
NXT Pro Urodynamics System	NXT2700	FDA UDI	Class II	Active
Pump Tube Set	9021O1196	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB680	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4065V-10cm	FDA UDI	Class II	Active
1-lumen Catheter for UPP, 8F	9021P1064	FDA UDI	Class II	Active
2-lumen Cystometry Pack	9021T1141	FDA UDI	Class II	Active
Urocap III	TRA711	FDA UDI	Class II	Active
Roam DX	RMX1000	FDA UDI	Class II	Active
3-lumen Catheter for Cystometry and Urethral	9021P5892	FDA UDI	Class II	Active
Pump Tube Set	9021O1186	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry 6 Fr. (400 mm)	9021P5262	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB806	FDA UDI	Class II	Active
Rectal Split Balloon Catheter	9021P4471	FDA UDI	Class II	Active
Tubing, Infusion Pump for Laborie Systems	TUBPTLAB	FDA UDI	Class II	Active
NuWav	PRB266	FDA UDI	Class II	Active
Remote Control NXT	RCX2001	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB725	FDA UDI	Class II	Active
2-lumen Cystometry Pack	9021T1091	FDA UDI	Class II	Active
Urocap IV Light	UCL2001	FDA UDI	Class II	Active
3-lumen UPP Pressure Catheter 9 Fr.	9021P5091	FDA UDI	Class II	Active
Triton	PRO835	FDA UDI	Class II	Active
Dual Lumen Catheter 7F	DLC-7D	EUDAMEDFDA UDI	Class II	Active
Coude Tip Triple Lumen Catheter 7F Radiopaque	CTLCXRO-7M	FDA UDI	Class II	Active
2-lumen Abdominal Pressure Catheter 9 Fr. Latex (200mm)	9021P4392	FDA UDI	Class II	Active
4 Ch. Single Use Anorectal Manometry Catheter-Stag	9012P1302	FDA UDI	Class II	Active
2-lumen Catheter	9021P0921	FDA UDI	Class II	Active
Urocap V	TRA1002	FDA UDI	Class II	Active
Catheter, Pves, Pura & Vinf, Triple Lumen, Radiopaque, 9Fr	CATW1B39EX	FDA UDI	Class II	Active
1-lumen Catheter for Cystometry 4 Fr. (300 mm)	9021P5642	FDA UDI	Class II	Active
Triton	PRO836	FDA UDI	Class II	Active
Tubing, Extension Line, 2 Set, Blue/Red, 150 cm	TUBEX2BR	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB620	FDA UDI	Class II	Active
Goby	GBS005	FDA UDI	Class II	Active
TDOC Air-Charged 7Fr Triple Lumen, Dual Sensor Bladder Catheter	CATT3B37	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB800	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry 8 Fr. (400 mm)	9021P5482	FDA UDI	Class II	Active
Peritron	PRN09300	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB630	FDA UDI	Class II	Active
Infusion Pump Tube Set with Dampening Chamber	IPTS-DC-LT1	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry 10 Fr. (400 mm)	9021P5502	FDA UDI	Class II	Active
Catheter, Pves & Vinf, Dual Lumen, Radiopaque, 8Fr	CATW1B28EX	FDA UDI	Class II	Active
Triton with Evox	PRO839	FDA UDI	Class II	Active
Coude Tip Triple Lumen Catheter 9F	CTLC-9M	FDA UDI	Class II	Active
Urocap IV Light	UCL1000	FDA UDI	Class II	Active
Cystometry Pack	9021T1061	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.