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HR HealthCare

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000008639

Devices
11
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
Authorised rep.
Emergo Europe B.V.NL

What HR HealthCare makes

HR HealthCare makes a range of medical devices, including intermittent catheters such as the EZ-Protect Hydrophilic Closed System Intermittent Catheter and the Liv Pre-lubricated Intermittent Catheter, as well as ultrasound-related products like the EcoVue and EcoVue HV. These devices are used for various medical purposes, including catheterization and ultrasound procedures. The company's product portfolio includes hydrophilic catheters and catheter kits.

The company's devices are classified as Class I and Class II medical devices and are listed in regulatory registries such as the FDA 510(k) database and Eudamed. HR HealthCare is based in the US, where it manufactures these medical devices. The devices are subject to regulatory oversight and must meet specific standards for safety and effectiveness.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • EcoVue Ref 386

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits Ref K251274

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Liv Pre-lubricated Intermittent Catheter Ref K260502

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EcoVue Ref 281

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EcoVue Ref 283

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EcoVue Ref 383

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EcoVue Ref 286

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EcoVue Ref 280

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EcoVue Ref 381

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EcoVue HV Ref 380

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • EcoVue Ref 284

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

Rows 1-11 of 11

Company details

EUDAMED SRN
US-MF-000008639
EUDAMED status
Active
EUDAMED registered name
HR HealthCare
Registered address
2600, Eastern Blvd, 17402, York, United States
Phone
877-302-1110
PRRC contact
Stacey Benser(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 29 Mar 2028

EUDAMED certificates (1)

Intertek Medical Notified Body AB 2862 1 certificate

  • 8620259250 Active

    Quality management system EU MDR

    Issued
    15 Oct 2026
    Expires
    29 Mar 2028

From the company website

Read 18 Sep 2026

HR HealthCare is a healthcare consumables manufacturer, specializing in medical lubricants and ultrasound gel to catheters, ostomy care and more.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does HR HealthCare have in the registry?

The registry currently lists 11 devices for HR HealthCare. Devices recorded under merged duplicate company entries are counted once.

Which registries list HR HealthCare's devices?

Among its 11 most recently registered devices, HR HealthCare has devices listed in EUDAMED (9 devices), FDA 510(k) (2 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do HR HealthCare's devices fall under?

Among its 11 most recently registered devices, the classes recorded for HR HealthCare's devices are Class I and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for HR HealthCare?

EUDAMED lists 1 certificate for HR HealthCare (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 15 Oct 2026.

What are the newest devices from HR HealthCare in the registry?

The most recently registered devices listed for HR HealthCare include EcoVue, EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits, Liv Pre-lubricated Intermittent Catheter and EcoVue HV.

Generated automatically from registry data and not verified by a human reviewer.