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Surgistar Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000003747

Devices
822
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.
Wellkang LtdXI

What Surgistar Inc. makes

Surgistar Inc. manufactures single-use surgical instruments, including scalpels, ophthalmic irrigation and aspiration cannulas, corneal trephines, and keratome blades. Their reusable products include scalpel handles, dental mirrors, and lacrimal intubation sets. These devices are designed for use in surgical, ophthalmic, and dental procedures.

The company’s portfolio is regulated under FDA Class I and Unclassified (U) devices and is listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue822

Newest first, rows 1-50 of 822

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  • Surgistar 8191

    Listed Registry: GUDID Class:I

  • Surgistar 8119

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

  • Surgistar 196469

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

  • Surgistar 8120

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

  • Surgistar 184921

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

  • Surgistar 1340

    Listed Registry: GUDID Class:I

  • Surgistar 496106

    Listed Registry: GUDID Class:I

  • Surgistar 125008

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

  • Surgistar 185217

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

  • Surgistar 5572

    Listed Registry: GUDID Class:I

  • Surgistar 5230

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

  • Surgistar 5520

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

  • Surgistar 962853

    Listed Registry: GUDID Class:I

  • Surgistar 6002

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

  • Surgistar 961618

    Listed Registry: GUDID Class:I

  • Surgistar, Inc. 965661

    Listed Registry: GUDID Class:I

  • Surgistar 961061

    Listed Registry: GUDID Class:I

  • Surgistar 101011

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

  • Surgistar 1685784

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

  • Surgistar 184489

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

  • Surgistar, Inc. 185214

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

  • Surgistar 8521

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

  • Surgistar 880250

    Listed Registry: GUDID Class:I

  • Surgistar 961520

    Listed Registry: GUDID Class:I

  • Surgistar 1394

    Listed Registry: GUDID Class:I

  • Surgistar 880300

    Listed Registry: GUDID Class:I

  • Surgistar 1685785

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

  • Surgistar 191105

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

  • Surgistar 962863

    Listed Registry: GUDID Class:I

  • Surgistar 126-MINDE-1.3AD

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

  • Surgistar 171604

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

  • Surgistar 0420

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

  • Surgistar 310875

    Listed Registry: GUDID Class:I

  • Surgistar 5486

    Listed Registry: GUDID Class:I

  • Surgistar 9500

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

  • Surgistar 961561

    Listed Registry: GUDID Class:I

  • Surgistar 585011

    Listed Registry: GUDID Class:—

  • Surgistar 885572

    Listed Registry: GUDID Class:I

  • Surgistar 125025

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

  • Surgistar 195181

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

  • Surgistar 8131

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

  • Surgistar 205250

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

  • Surgistar 882569

    Listed Registry: GUDID Class:I

  • Surgistar 131631

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

  • Surgistar 6825

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

  • Surgistar 990-002

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

  • Surgistar MR3

    Listed Registry: GUDID Class:I

  • Surgistar S6200

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

  • Surgistar 5522BU

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

  • Surgistar 360785

    Listed Registry: GUDID Class:I

Rows 1-50 of 822

Showing 1-50 of 822

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000003747
DUNS number
808865125
EUDAMED status
Active
EUDAMED registered name
Surgistar Inc.
Registered address
2310, La Mirada Dr., 92081, Vista, United States
Phone
+1 760 598 2480
PRRC contact
Don Duong(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 29 Jun 2027

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 750789 Expiring Supplemented Expires in 229 days

    Quality assurance EU MDR

    Issued
    11 Jun 2026
    Expires
    29 Jun 2027
    Reason
    Add device or group

Frequently asked questions

How many devices does Surgistar Inc. have in the registry?

The registry currently lists 822 devices for Surgistar Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Surgistar Inc.'s devices?

Among its 50 most recently registered devices, Surgistar Inc. has devices listed in FDA GUDID (50 devices).

What risk classes do Surgistar Inc.'s devices fall under?

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

What EUDAMED certificates are recorded for Surgistar Inc.?

EUDAMED lists 1 certificate for Surgistar Inc. (quality assurance) under MDR. The most recent was issued on 11 Jun 2026.

What are the newest devices from Surgistar Inc. in the registry?

The most recently registered devices listed for Surgistar Inc. include SURGISTAR 8191, SURGISTAR 8119, SURGISTAR 196469 and SURGISTAR 8120.

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