Is this your brand? Sign in to claim ownership.

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 1 of 6

Device	Model / Reference	Registries	Class	Status
Wire Electrode Needle Set Female	1512A-F	FDA UDI	Class II	Active
Ita	ITA	FDA UDI	Class II	Active
2-lumen Abdominal Pressure Catheter 12 Fr. Latex (300mm)	9021P4422	FDA UDI	Class II	Active
3-lumen Catheter for Profile and Bladder Pressure	9021P5803	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB770	FDA UDI	Class II	Active
Triple Lumen Catheter 7F Radiopaque Male	TLCXRO-7M	FDA UDI	Class II	Active
Catheter, Pves only, Single Lumen, 4.5Fr	CATW1B15E	FDA UDI	Class II	Active
Catheter, Pabd, Single Lumen, Closed Balloon, Latex, 12Fr	CATW1A112BL	FDA UDI	Class II	Active
NuWav	PRB262	FDA UDI	Class II	Active
Dorado KT	Dorado KT	FDA UDI	Class II	Active
Urocap NXT	UCX2001	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB751	FDA UDI	Class II	Active
All Purpose Tubing Set	APT	FDA UDI	Class II	Active
PIM NXT for TDOC	PIX2211	FDA UDI	Class II	Active
SondeAR - Air Charged Catheter	SAR-AL	FDA UDI	Class II	Active
Probe, Manometry, Vaginal Sensor	PRB113	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry 8 Fr. (400 mm)	9021P5282	FDA UDI	Class II	Active
Infusion Pump Tube Set	IPTSA-LT1	FDA UDI	Class II	Active
Catheter, Pabd, Dual Lumen, Closed Balloon, Latex, 12Fr	CATW1A212BL	FDA UDI	Class II	Active
Catheter, Pves & Vinf, Dual Lumen, 10Fr	CATW1B210E	FDA UDI	Class II	Active
NXT Go Pump Hub	DCX2101	FDA UDI	Class II	Active
8 Ch. Single Use Anorectal Manometry Catheter	9012P1422	FDA UDI	Class II	Active
injeTAK Adjustable Tip Needle 70cm	DIS201	FDA UDI	Class II	Active
2-lumen Abdominal Pressure Catheter 12 Fr. Latex (300mm)	9021P4442	FDA UDI	Class II	Active
UDS Roam	PLM001	FDA UDI	Class II	Active
Coude Dual Lumen Catheter 7F	CDLC-7D	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4030P4	FDA UDI	Class II	Active
Tubing, Extension Line, Red for Pabd, 150 cm	TUBEX1R	FDA UDI	Class II	Active
2-lumen Catheter for UPP, 9F	9021P5892	FDA UDI	Class II	Unknown
Goby	GBS007	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB716	FDA UDI	Class II	Active
Rectal Split Balloon Catheter	9021P4460	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB750	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4550A	FDA UDI	Class II	Active
TDOC Air-Charged 7Fr Dual Lumen, Single Sensor Bladder Catheter	CATT3B27	FDA UDI	Class II	Active
T-DOC Air-Charged Stylet	DIS500	FDA UDI	Class II	Active
2-lumen Catheter for Abdominal Pressure	9021P4592	FDA UDI	Class II	Active
Dual Infusion Pump Tube Set	DIPTS-LT1	FDA UDI	Class II	Active
Rectal Flap Catheter	9021P4480	FDA UDI	Class II	Active
NuWav	PRB265	FDA UDI	Class II	Active
2-lumen Multi Point Catheter for Cystometry and Urethral Pressure	9021P5812	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4023V	FDA UDI	Class II	Active
Disposable Transducer Cartridge	2800C	FDA UDI	Class II	Active
Pump Tube Set	400120018	FDA UDI	Class II	Active
2-lumen Catheter	9021P0911	FDA UDI	Class II	Active
UPP Puller NXT	UPX2001	FDA UDI	Class II	Active
Aquarius XT	AQS3003	FDA UDI	Class II	Active
Pump Tubing Infusion Line with SmartSense Tag	TUB500-RFID	FDA UDI	Class II	Active
Cystometry Pack	9021T1011	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB797	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.