Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010872792

FEI Number

3010872792

Entity Name

LILMO Ltd

City/State/Country

PAMPLEMOUSSES, MU

Establishment Address

Route Royale, Canton Bel Eau, PAMPLEMOUSSES N/A, MU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Perouse Medical (Owner Number: 10046668)

Owner / Operator Contact Address

Batiment LW1 1 Route Des Troques, Chaponost, FR-ARA 69630, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MyShell Lite Dolphin Inflation Device POLYPERF with injection site POLYPERF SAFE without injection site POLYPERF without injection site POLYPERF SAFE with injection site PPS PI® Pressure Injectable Safety Huber Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2024-12-02
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2017-01-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-08-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-08-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-04-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

Chris Steinke Business: VYGON USA Email: csteinke@vygon.com Phone: (603) 7435988

Related Public Records

Same Entity

Perouse Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006942524	Perouse Medical	FRANCE Oise, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

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9612152	ELCAM MEDICAL A.C.A.L.	D.N. MEROM HAGALIL Northern, IL
2184009	MEDTRONIC PERFUSION SYSTEMS	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010872792. Last updated year: 2026. Please use registration number 3010872792 when referencing this establishment in official correspondence.