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Dex Surgical

Active in EUDAMED

Francefrom SRN EUDAMED SRN FR-MF-000009703

Dex Surgical is a medical device manufacturer based in France, with 29 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIb; FDA Class II) as of 13 Nov 2026.

Devices
29
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 21
  • FDA GUDID 10
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class IIb 18
  • FDA Class II 11
Top EMDN categories
Identifiers
  • EUDAMED SRN FR-MF-000009703
  • DUNS 268845728

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

What Dex Surgical makes

Dex Surgical manufactures endoscopic electromechanical surgical systems, including components like monopolar scissors, needle holders, Maryland dissectors, and applicator tools. The systems also feature control handles, protection sleeves, and a central control unit designed for minimally invasive procedures.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identification (UDI) databases. The portfolio is regulated in the United States, where the manufacturer is based.

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

Catalogue29

Newest first, rows 1-29 of 29

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  • Arm needle holder long Ref B-1301C40L

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Hook long Ref B-1506C60L

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Maryland long Ref B-1505C40L

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Monopolar Scissors long Ref B-1304C20L

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm needle holder Ref B-1301C40N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Hook F Ref B-1506C40N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Monopolar Scissors Ref B-1304C20N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm needle holder demo Ref B-1301D20N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Maryland demo Ref B-1505D20N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Maryland F Ref B-1505C20N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Maryland Ref B-1505C40N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Console and handle left Ref EP-1302

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Console and handle right Ref EP-1301

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Monopolar Scissors F Ref B-1304C10N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Monopolar Scissors demo Ref B-1304D10N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Hook Ref B-1506C60N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm needle holder F Ref B-1301C20N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Arm Hook demo Ref B-1506D20N

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Control Handle Left P-1302

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Monopolar protection sleeve M-1304

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

  • Arm Monopolar hook B-1506

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

  • Control Unit E-1301

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Sleeve applicator tool P46732

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

  • Arm Monopolar scissors B-1304

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

  • Arm Needle holder B-1301

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

  • Arm Monopolar Maryland B-1505

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

  • Protection sleeve 2090-MDS

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

  • Control handle P-1301

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • DEX Device Ref K191878

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

Rows 1-29 of 29

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000009703
DUNS number
268845728
EU VAT number
FR24821816790
EUDAMED status
Active
EUDAMED registered name
DEX Surgical
Registered address
8, avenue de novel, 74000, Annecy, France
PRRC contact
Margaux JANIER(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 29 Oct 2030

EUDAMED certificates (1)

GMED SAS 0459 1 certificate

  • 40352 Active Supplemented

    Quality management system EU MDR

    Issued
    27 Aug 2026
    Expires
    29 Oct 2030
    Reason
    Other

Frequently asked questions

How many devices does DEX SURGICAL have in the registry?

The registry currently lists 29 devices for DEX SURGICAL. Devices recorded under merged duplicate company entries are counted once.

Which registries list DEX SURGICAL's devices?

Among its 29 most recently registered devices, DEX SURGICAL has devices listed in EUDAMED (21 devices), FDA 510(k) (1 device) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do DEX SURGICAL's devices fall under?

Among its 29 most recently registered devices, the classes recorded for DEX SURGICAL's devices are Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for DEX SURGICAL?

EUDAMED lists 1 certificate for DEX SURGICAL (quality management system) under MDR. The most recent was issued on 27 Aug 2026.

What are the newest devices from DEX SURGICAL in the registry?

The most recently registered devices listed for DEX SURGICAL include Arm needle holder long, Arm Hook long, Arm Maryland long and Arm Monopolar Scissors long.

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