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Fluoptics SAS

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000000403 FEI 3011092264

Fluoptics SAS is a medical device manufacturer based in France, with 23 devices listed in EUDAMED (EU Class IIa and I) as of 13 Nov 2026.

Devices
23
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 23
Device classes
  • EU Class IIa 20
  • EU Class I 3
Top EMDN categories
Identifiers
  • EUDAMED SRN FR-MF-000000403
  • FDA FEI 3011092264

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
United States
FDA establishment

What Fluoptics SAS makes

Fluoptics SAS manufactures fluorescence imaging systems, including the Fluobeam LS, LM, and LX series, as well as the Fluoclip and Fluocart accessories. The company also produces Fluosoft software, including the LX, LS, and LX Red versions, designed for use with their imaging hardware.

The company is based in France, and its portfolio consists of Class I and Class IIa medical devices. These products are listed in the Eudamed database.

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

Catalogue23

Newest first, rows 1-23 of 23

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  • FLUOBEAM 800 system Ref CS_FB800_IS

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa

  • Fluobeam Lm Ref FBLM

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM LM system Ref CS_FBLM_PC

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM 800 system Ref CS_FB800

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa

  • FLUOBEAM LS system Ref CS_FBLS_DU

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Fluoclip Ref LXHO

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • FLUOBEAM LM system Ref CS_FBLM

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Fluobeam Ls Ref FBLS

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Fluosoft Lx Ref FSLX-CL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM LS system Ref CS_FBLS_IS

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM LS system Ref CS_FBLS_PC

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Fluocart Ref FK-CL

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Fluosoft Ls Ref FSLS

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM LM system Ref CS_FBLM_PC_A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOSOFT LX Red Ref FSLXR-CL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM LX system Ref CS_FBLX_DU

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM LM system Ref CS_FBLM_DU

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • FLUOBEAM LX Red system Ref CS_FBLXR_PC

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • FLUOBEAM LX system Ref CS_FBLX_PC_A

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • Fluosoft Lm Ref FSLM-CL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Fluosoft Ref FS-CL

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa

  • Fluopod Ref FMSA

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • FLUOBEAM 800 system Ref CS_FB800_PC_A

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIa

Rows 1-23 of 23

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000000403
SRN (system / procedure pack)
FR-PR-000002882
FDA FEI number
3011092264
EU VAT number
FR47510508716
EUDAMED status
Active
EUDAMED registered name
FLUOPTICS SAS
Registered address
44, rue des berges, 38000, Grenoble, France
PRRC contact
Marion BOUDET(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 27 Nov 2027

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • DZ 1224696-1 Active Amended

    Quality assurance EU MDR

    Issued
    14 Mar 2024
    Expires
    27 Nov 2027
    Reason
    Other

FDA establishments1

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

  • Fluoptics US

Frequently asked questions

How many devices does FLUOPTICS SAS have in the registry?

The registry currently lists 23 devices for FLUOPTICS SAS. Devices recorded under merged duplicate company entries are counted once.

Which registries list FLUOPTICS SAS's devices?

Among its 23 most recently registered devices, FLUOPTICS SAS has devices listed in EUDAMED (23 devices).

What risk classes do FLUOPTICS SAS's devices fall under?

Among its 23 most recently registered devices, the classes recorded for FLUOPTICS SAS's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for FLUOPTICS SAS?

EUDAMED lists 1 certificate for FLUOPTICS SAS (quality assurance) under MDR. The most recent was issued on 14 Mar 2024.

What are the newest devices from FLUOPTICS SAS in the registry?

The most recently registered devices listed for FLUOPTICS SAS include FLUOBEAM 800 system, FLUOBEAM LM, FLUOBEAM LM system and FLUOBEAM LS system.

Which FDA establishments are linked to FLUOPTICS SAS?

1 FDA establishment is linked to FLUOPTICS SAS in the registry; they are listed on the company page.

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