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Hydrofera, LLC

United Statesfrom the FDA registration address FDA FEI 3019543072

Hydrofera, LLC is a medical device manufacturer, with 54 devices listed in FDA GUDID and FDA 510(k) (FDA Unclassified, Class I and Class II) as of 14 Nov 2026.

Devices
54
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 48
  • FDA 510(k) 7

A device listed in two registries counts in both.

Device classes
  • FDA Unclassified 52
  • FDA Class I 1
  • FDA Class II 1
Sites and related companies
Identifiers
  • FDA FEI 3019543072
  • DUNS 080660602

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Hydrofera, LLC makes

Hydrofera, LLC manufactures permeable, antimicrobial, non-adherent wound dressings. Their product line includes the Hydrofera Blue, Hydrofera Blue Classic, and Hydrofera Blue Ready series, which are available in various configurations such as border and TSD versions.

These products are classified as Class U devices.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue54

Newest first, rows 1-50 of 54

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  • Hydrofera Blue HBRF2258

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRB3810

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBHD6675

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBT0906

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HB4414E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HB6614E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRF2650E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRS3535

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBCC6675

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRT8080

    Listed Registry: GUDID Class:—

  • Hydrofera Blue HBRT2525E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRS4520

    Listed Registry: GUDID Class:—

  • Hydrofera Blue HBRB6080E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRB3875

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRB4040

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRS8820E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HB4414

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRF2650

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRS2520E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRB6080

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRS2520

    Listed Registry: GUDID Class:—

  • Hydrofera Blue HBRS8820

    Listed Registry: GUDID Class:—

  • Hydrofera Blue HB4514E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBCC4450

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HB2214

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBT0906E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBCC6675E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRF4475

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBHD4450

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRF4414

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRB5959

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRT4050E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRS3535E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBHD4450E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRT4050

    Listed Registry: GUDID Class:—

  • Hydrofera Blue HBRB5959E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBCC4550

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRS4520E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBHD6675E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HB4514

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRT2525

    Listed Registry: GUDID Class:—

  • Hydrofera Blue HBRB4040E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HB6614

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRB3813

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBCC4550E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HBRT8080E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue HB2214E

    Active Regimes: 510(k) Registry: GUDID Class:—

  • Hydrofera Blue Pu Bacteriostatic Dressing Ref K130670

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

  • Hydrofera Surgical Spear Ref K974313

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

  • Hydrofera Bacteriostatic Wound Dressing Ref K013462

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

Rows 1-50 of 54

Showing 1-50 of 54

Company details

FDA FEI number
3019543072
DUNS number
080660602
Address
8 Progress Drive, Manchester, CT, 06042

Sites1

Frequently asked questions

How many devices does HYDROFERA, LLC have in the registry?

The registry currently lists 54 devices for HYDROFERA, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list HYDROFERA, LLC's devices?

Among its 50 most recently registered devices, HYDROFERA, LLC has devices listed in FDA 510(k) (3 devices) and FDA GUDID (47 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do HYDROFERA, LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for HYDROFERA, LLC's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from HYDROFERA, LLC in the registry?

The most recently registered devices listed for HYDROFERA, LLC include Hydrofera Blue HBRF2258, Hydrofera Blue HBRB3810, Hydrofera Blue HBHD6675 and Hydrofera Blue HBT0906.

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