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Summit Medical, LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000026771 FEI 1000120904

Summit Medical, LLC is a medical device manufacturer based in the United States, with 8,403 devices listed as of 12 Nov 2026.

Devices
8,403
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 2,990
  • EUDAMED 2,733

Among the 3,000 best-ranked of 8,403 devices.

Device classes
  • EU Class I 2,307
  • FDA Class II 584
  • FDA Class I 65
  • EU Class IIb 39
  • FDA Unclassified 5

Among the 3,000 best-ranked of 8,403 devices.

Top EMDN categories

Among the 3,000 best-ranked of 8,403 devices.

Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000026771
  • FDA FEI 1000120904

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment
Authorised rep.
MDSS GmbHDE

Catalogue8,403

Newest first, rows 1-50 of 8,403

Search and filter all 8,403 devices
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  • Instrusafe In-2020-8304

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

  • Instrusafe In-2020-8242

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

  • Instrusafe In-2020-8250

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

  • Instrusafe In-2020-8176

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

  • Instrusafe In-2020-8315

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

  • Instrusafe In-2020-8312

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

  • Instrusafe In-2020-8248

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

  • Instrusafe In-2020-8355

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

  • Instrusafe In-2020-8175

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

  • Instrusafe In-2020-7849

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

  • Instrusafe In-2020-8300

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

  • Instrusafe In-2020-8294

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

  • Instrusafe In-3030-0326

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

  • Instrusafe In-2300-05-En-154

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

  • Instrusafe In-2300-05-En-155

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

  • Instrusafe In-2300-05-En-156

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

  • Instrusafe In-2300-05-En-150

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

  • Instrusafe In-2020-8012

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

  • Instrusafe In-2300-05-En-151

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

  • Instrusafe In-2020-8216

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

  • Instrusafe In-2020-8295

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

  • Instrusafe In-2020-8025

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

  • Instrusafe In-2020-8273

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

  • Instrusafe In-2020-8228

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

  • Instrusafe In-2020-7735

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

  • Instrusafe In-2020-8284

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

  • Instrusafe In-2020-8172

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

  • Instrusafe In-2020-8123

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

  • Instrusafe In-2020-7910

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

  • Instrusafe In-2020-8215

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

  • Instrusafe In-2020-8125

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

  • Instrusafe In-2020-8285

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

  • Instrusafe In-2020-8258

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

  • Instrusafe In-2020-8011

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

  • Instrusafe In-2300-05-En-152

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

  • Instrusafe In-2300-05-En-153

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

  • InstruSafe Ref IN-2020-0526

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0137

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0186

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0648

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0719

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0529

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0543

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-4289

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0462

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • InstruSafe Ref IN-2020-0681

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Instrusafe In-2020-8160

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

  • Instrusafe In-2020-7447

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

  • Instrusafe In-2020-8106

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

  • Instrusafe In-2020-8238

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

Rows 1-50 of 8,403

Showing 1-50 of 8,403

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000026771
FDA FEI number
1000120904
EUDAMED status
Active
EUDAMED registered name
Summit Medical, LLC
EUDAMED abbreviated name
Summit Medical
Registered address
815, Vikings Parkway, 55121, St. Paul, United States
Phone
+1 651-789-3939
PRRC contact
Ajay Boodhun(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Summit Medical Ltd GB

Frequently asked questions

How many devices does Summit Medical, LLC have in the registry?

The registry currently lists 8403 devices for Summit Medical, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Summit Medical, LLC's devices?

Among its 50 most recently registered devices, Summit Medical, LLC has devices listed in EUDAMED (10 devices) and FDA GUDID (40 devices). A device can be listed in more than one registry, so these counts overlap.

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

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

What are the newest devices from Summit Medical, LLC in the registry?

The most recently registered devices listed for Summit Medical, LLC include INSTRUSAFE IN-2020-8304, INSTRUSAFE IN-2020-8242, INSTRUSAFE IN-2020-8250 and INSTRUSAFE IN-2020-8176.

Which FDA establishments are linked to Summit Medical, LLC?

1 FDA establishment is linked to Summit Medical, LLC in the registry; they are listed on the company page.

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