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 5 of 6

Device	Model / Reference	Registries	Class	Status
Extension Line, 1500mm	9021P6332	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB679	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry and Urethral	9021P5082	FDA UDI	Class II	Active
Goby Hub	GBH001	FDA UDI	Class II	Active
Urostym	PRO180	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB671	FDA UDI	Class II	Active
Rectal Flap Catheter	9021P4450	FDA UDI	Class II	Active
Cystometry Pack	9021T1081	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4065A-10cm	FDA UDI	Class II	Active
Delphis KT	Delphis KT	FDA UDI	Class II	Active
UPP Puller Controller Aquarius	UPP1000	FDA UDI	Class II	Active
Infusion Set	9021O1176	FDA UDI	Class II	Active
Aquarius CTS	AQS2002	EUDAMEDFDA UDI	Class II	Active
UPP Puller	UPP715	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB752	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB689	FDA UDI	Class II	Active
Tubing, Infusion Pump for Andromeda Systems	TUBPTAND	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB760	FDA UDI	Class II	Active
Dual Lumen Catheter 9F	DLC-9D	FDA UDI	Class II	Active
Tube for Vaginal Sensor, with 3-way Stopcock	PRB080	FDA UDI	Class II	Active
Infusion Set for Pump	9021O1175	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4065U-10cm	FDA UDI	Class II	Active
4 Ch. Single Use Anorectal Manometry Catheter	9012P1432	FDA UDI	Class II	Active
Perfusion Set 3	9021P6032	FDA UDI	Class II	Active
Tubing, Extension Line, 3 Set, Blue/Red/Yellow, 150 cm	TUBEX3BRY	FDA UDI	Class II	Active
Dampening Chamber with Infusion Restrictor Tube	DCIT-RT	FDA UDI	Class II	Active
Pump Tube Set	9021O1236	FDA UDI	Class II	Active
Extension Set 3	9021P1293	FDA UDI	Class II	Active
2-lumen Abdominal Pressure Catheter 12 Fr. Latex (200mm)	9021P4461	FDA UDI	Class II	Active
Urocap IV Light	UCL1001	FDA UDI	Class II	Active
Delphis KT	Delphis KT	FDA UDI	Class II	Active
Pump Tube Set for Andromeda	9021O2041	FDA UDI	Class II	Active
Extension Line, 150cm Red	9021P6361	FDA UDI	Class II	Active
2-lumen Catheter Pack	9021T1001	FDA UDI	Class II	Active
Triple Lumen Catheter 7F Radiopaque Female	TLCXRO-7F	FDA UDI	Class II	Active
2-lumen Catheter for Cystometry 8 Fr. (400 mm)	9021P5382	FDA UDI	Class II	Active
Coude Dual Lumen Catheter 6F	CDLC-6D	FDA UDI	Class II	Active
Tubing, Extension Line, Blue for Pves, 150 cm	TUBEX1B	FDA UDI	Class II	Active
Rectal Split Balloon Catheter	9021P4470	FDA UDI	Class II	Active
NuWav	PRB260	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB798	FDA UDI	Class II	Active
2-lumen Catheter Pack	9021T1071	FDA UDI	Class II	Active
Infusion Pump Tube Set	IPTSA-LT2	FDA UDI	Class II	Active
Urocap III	TRA709	FDA UDI	Class II	Active
Extension Line, 150cm Yellow	9021P6381	FDA UDI	Class II	Active
Aquarius CT	AQS2000	FDA UDI	Class II	Active
Extension Line, 60 cm	9021P6312	FDA UDI	Class II	Active
Catheter, Pves, Pura & Vinf, Triple Lumen, Perfusion, 7Fr	CATW1U37ER	FDA UDI	Class II	Active
Catheter, Pura & Pves, Dual Lumen, 6Fr	CATW1U26E	FDA UDI	Class II	Active
Air-Charged Reusable Cable	CAB4550P4	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.