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Hexacath

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000010342 FEI 3013134719

Hexacath is a medical device manufacturer based in France, with 64 devices listed in EUDAMED, FDA 510(k) and FDA GUDID (EU Class III and IIb; FDA Class II) as of 14 Nov 2026.

Devices
64
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 62
  • FDA 510(k) 1
  • FDA GUDID 1

A device listed in two registries counts in both.

Device classes
  • EU Class III 61
  • FDA Class II 2
  • EU Class IIb 1
Top EMDN categories
Identifiers
  • EUDAMED SRN FR-MF-000010342
  • FDA FEI 3013134719
  • DUNS 398534461

At a glance

Counted by deviCERTS from registry records

EU certificates

3 of 3 in force.

See certificates

Market reach

European Union
EUDAMED actor, 3 certificates
United States
FDA FEI

What Hexacath makes

Hexacath manufactures coronary artery infusion catheters, including the RAYFLOW and RayFlow models, designed for targeted drug delivery or perfusion during interventional procedures.

The company’s devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue64

Newest first, rows 1-50 of 64

Search and filter all 64 devices
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  • Titan Optimax Ref LICM 35-22 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-32 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-32 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-7 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-13 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-28 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-16 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-16 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-25 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 20-13 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 50-13 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-22 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-16 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-13 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 35-7 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-13 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 50-19 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-7 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 225-16 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-22 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-25 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-19 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-25 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-28 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-38 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 35-28 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-7 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 225-10 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 35-16 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-22 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-19 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-19 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-13 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-25 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-10 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 35-25 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-10 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-28 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 45-13 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 35-19 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 45-16 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 30-38 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-16 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 20-7 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 45-19 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 40-38 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 25-28 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 35-32 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 275-32 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Titan Optimax Ref LICM 20-10 OPTI

    Active Regimes: CE MDR Registry: EUDAMED Class:III

Rows 1-50 of 64

Showing 1-50 of 64

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000010342
FDA FEI number
3013134719
DUNS number
398534461
EU VAT number
FR94340075787
EUDAMED status
Active
EUDAMED registered name
HEXACATH
Registered address
2, Rue Joseph Monier, 92500, Rueil Malmaison, France
Phone
+33141390192
PRRC contact
Elodie DA SILVA(public in EUDAMED)

EUDAMED certificates3

3 certificates3 valid, 0 expiredMDR 3next expiry 26 Oct 2031

EUDAMED certificates (3)

GMED SAS 0459 3 certificates

  • 38665 Active Supplemented

    Quality management system EU MDR

    Issued
    7 Oct 2026
    Expires
    26 Oct 2031
    Valid from
    27 Oct 2026
    Reason
    Other
  • 38666 Active Reissued

    Technical documentation EU MDR

    Issued
    28 Aug 2026
    Expires
    26 Oct 2031
    Valid from
    27 Oct 2026
  • 39119 Active Reissued

    Quality management system EU MDR

    Issued
    29 Jul 2026
    Expires
    26 Oct 2031
    Valid from
    27 Oct 2026

Frequently asked questions

How many devices does Hexacath have in the registry?

The registry currently lists 64 devices for Hexacath. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hexacath's devices?

Among its 50 most recently registered devices, Hexacath has devices listed in EUDAMED (50 devices).

What risk classes do Hexacath's devices fall under?

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

What EUDAMED certificates are recorded for Hexacath?

EUDAMED lists 3 certificates for Hexacath (quality management system; technical documentation) under MDR. The most recent was issued on 7 Oct 2026.

What are the newest devices from Hexacath in the registry?

The most recently registered devices listed for Hexacath include TITAN OPTIMAX.

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