Manufacturer

Laborie

United StatesLegal entities : Laborie Medical Technologies Corp.

Markets : Belgium · France · Netherlands · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 24 · class I, II · latest in 2024 · see on the FDA website

Public contracts won : France 90 · Belgium 2

EU representative : Medical Measurement Systems B.V. (Netherlands)

7 categories, 26 models including 25 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Urodynamics systems	Z12160401	Aquarius Urodynamic Analyzer System AQS200293/42 Aquarius Urodynamic Analyzer System AQS200493/42 Aquarius Urodynamic Analyzer System AQS300093/42 Aquarius Urodynamic Analyzer System AQS300193/42 Aquarius Urodynamic Analyzer System AQS300293/42 10 others Aquarius Urodynamic Analyzer System AQS300393/42 Aquarius Urodynamic System AQS100093/42 Aquarius Urodynamics Analyzer System AQS200093/42 Aquarius Urodynamics Analyzer System AQS200193/42 Aquarius Urodynamics System AQS100193/42 GOBY Urodynamic Analyzer System GBS00593/42 GOBY Urodynamic Analyzer System GBS00693/42 Goby Urodynamics Analyzer System GBS00793/42 Nexam Pro CIM H4E2 refs Solar Blue, Laptop2 refs	IIa MDR, 93/42	EUDAMED record Report an error
Urodynamics instruments - consumables	Z12160485	2-lumen Catheter for Cystometry 10 Fr. (400 mm) 9021P50623 refs 4-Way Stop Cock TUB1013 refs eSense® Urodynamic Catheters CATEB273 refs T-DOC Air-Charged Catheters CAT8753 refs UniTip Catheter3 refs (no longer marketed)	IIa MDR	EUDAMED record Report an error
Uroflowmeters	Z121605	Flowmaster U1-1 Flowstar U2-1	I MDR	EUDAMED record Report an error
Gastric pH monitor	Z120704	Ohmega G2-1	I MDR	EUDAMED record Report an error
Gastroenterology instruments - consumables	Z120785	UniTip High Resolution Catheter K83659-E-1820-D3 refs	IIa MDR	EUDAMED record Report an error
Gastroesophageal pH holter recorders	Z120702	SOLAR COMPACT G4-13 refs	IIa MDR	EUDAMED record Report an error
Tens system electrodes	N010201	DIS7000	I MDR	EUDAMED record Report an error

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