Is this your brand? Sign in to claim ownership.

Laborie Medical Technologies Corp.

United States·US-MF-000022925

Last updated September 17, 2026

Information

Country: United States
Address: 180 International Drive , Portsmouth, United States
Website: laborie.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 18012606086
PRRC Contact: Thomas Hirte
EUDAMED SRN: US-MF-000022925
FDA FEI Number: 3017448360
DUNS Number: —

Catalogue (88)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Flowstar	U2-1	EUDAMEDFDA UDI	Class I	Active
Air-Charged Reusable Cable	TRA621	EUDAMEDFDA UDI	Class I	Active
EMG Shorting Leads, Non-shielded	CAB151	EUDAMED	Class I	Active
T-DOC Air-Charged Dual Sensor Catheter, Radiopaque	CAT885	EUDAMEDFDA UDI	Class IIa	Active
Air-Charged Reusable Cable	CAB815	EUDAMEDFDA UDI	Class I	Active
EMG Cable, Shielded, Short	CAB1033	EUDAMEDFDA UDI	Class I	Active
T-DOC Air-Charged Dual Sensor Catheter	CAT880	EUDAMEDFDA UDI	Class IIa	Active
2-lumen Catheter for Cystometry and Urethral	9021P5062	EUDAMEDFDA UDI	Class IIa	Active
Air-Charged Reusable Cable	CAB4060P4S	EUDAMEDFDA UDI	Class I	Active
Air-Charged Reusable Cable	CAB635	EUDAMEDFDA UDI	Class I	Active
Air-Charged Reusable Cable	TRA617	EUDAMEDFDA UDI	Class I	Active
T-DOC Air-Charged Single Sensor Coudé Catheter	CAT878	EUDAMEDFDA UDI	Class IIa	Active
Air-Charged Reusable Cable	TRA615	EUDAMEDFDA UDI	Class I	Active
Transducer TDOC cable, Abdominal, MMS 25cm	CAB4065A-25cm	EUDAMEDFDA UDI	Class I	Active
EMG Cable, Shielded, Long	CAB1035	EUDAMEDFDA UDI	Class I	Active
Transducer TDOC cable, Urethral, MMS 25cm	CAB4065U-25cm	EUDAMEDFDA UDI	Class I	Active
injeTAK Adjustable Tip Needle (35 cm)	DIS199-E	EUDAMED	Class IIa	Active
Aquarius Urodynamics System	AQS1001	EUDAMEDFDA UDI	Class IIa	Active
Air-Charged Reusable Cable	CAB4060US	EUDAMEDFDA UDI	Class I	Active
Cbl, Sedia, Abd	CAB4520A	EUDAMEDFDA UDI	Class I	Active
Air-Charged Reusable Cable	CAB4060AS	EUDAMEDFDA UDI	Class I	Active
Anorectal Manometry Catheter	CAT003	EUDAMEDFDA UDI	Class IIa	Active
EMG Shorting Leads, Shielded	CAB150	EUDAMEDFDA UDI	Class I	Active
Aquarius Urodynamic System	AQS1000	EUDAMEDFDA UDI	Class IIa	Active
EMG Cable, Non-shielded, Short	CAB1032	EUDAMEDFDA UDI	Class I	Active
Cbl, Sedia, Ves	CAB4520V	EUDAMEDFDA UDI	Class I	Active
injeTAK Adjustable Tip Needle (70 cm)	DIS201-E	EUDAMED	Class IIa	Active
Air-Charged Reusable Cable	TRA620	EUDAMEDFDA UDI	Class I	Active
EMG Cable, Non-shielded, Long	CAB1034	EUDAMEDFDA UDI	Class I	Active
Medex Pressure Cable, P4	CAB1040	EUDAMEDFDA UDI	Class I	Active
Flowmaster	U1-1	EUDAMEDFDA UDI	Class I	Active
Channel 3, Urostym, Manometry Cable	TRA168	EUDAMED	Class I	Active
Cable, Urostym, Channel 2	CAB906	EUDAMEDFDA UDI	Class I	Active
Medex Pressure Cable, P3	CAB1039	EUDAMEDFDA UDI	Class I	Active
Cable, Urostym, Channel 1	CAB896	EUDAMEDFDA UDI	Class I	Active
-DOC ARM Adaptor Cable	CAB4065P4S	EUDAMEDFDA UDI	Class I	Active
Cbl, Sedia, Ura	CAB4520U	EUDAMEDFDA UDI	Class I	Active
Medex Pressure Cable, P1	CAB1036	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Medical Measurement Systems B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 17, 2019	Z-2076-2019	—	terminated	Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
Oct 4, 2006	Z-0229-2007	—	terminated	Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041