Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007360714

FEI Number

3007360714

Entity Name

HERSILL, S.L.

City/State/Country

MOSTOLES (MADRID) Madrid (Province), ES

Establishment Address

C/ PUERTO DE NAVACERRADA, 3, MOSTOLES (MADRID) Madrid (Province) 28935, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HERSILL, S.L. (Owner Number: 10027484)

Owner / Operator Contact Address

C/ PUERTO DE NAVACERRADA, 3, MOSTOLES (MADRID), ES-M 28935, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093241

PMA Number

N/A

All Registered Proprietary Names

WATER COLUMN COLLECTION JARS PERFLOW HUMIDIFIER VACUP ELITE VACUP PRO FLOW SELECTOR P-300 V7 PORTABLE SUCTION UNITS Care-e-vac EMS Care-e-vac Plus Care-e-vac C/I

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBD	Bottle, Collection, Breathing System (Calibrated)	General Hospital	Class 2	880.6740	2008-11-12
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2008-11-12
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Anesthesiology	Class 1	868.2300	2008-11-12
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2008-11-12
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2008-11-12
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2008-11-12
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2008-11-12
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2010-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

MANUEL MATEOS Business: CMC MEDICAL DEVICES, LLC Email: fdaagent@cmcmedicaldevices.com Phone: (407) 2058993

Related Public Records

Same Entity

HERSILL, S.L.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007360714. Last updated year: 2026. Please use registration number 3007360714 when referencing this establishment in official correspondence.