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Sedatelec

Active in EUDAMED

Francefrom SRN EUDAMED SRN FR-MF-000020946

Sedatelec is a medical device manufacturer based in France, with 48 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIa and I; FDA Class II and I) as of 15 Nov 2026.

Devices
48
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 35
  • FDA GUDID 31
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • EU Class IIa 29
  • FDA Class II 7
  • FDA Class I 6
  • EU Class I 3
  • EU Class IIb 3
Top EMDN categories
Identifiers
  • EUDAMED SRN FR-MF-000020946
  • DUNS 266031462
  • Other registry ID 5711

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 Sedatelec makes

Sedatelec manufactures clinical external manual massagers and single-use acupuncture needles. Their product line includes pressure feelers (e.g., PAL250, EASYO 1) for therapeutic applications, glass rods for acupuncture, and disposable needles (e.g., FOREVER NEEDLE REGULAR, ASP Original GOLD 80). They also produce laser devices, such as the PREMIO 30 EVO Laser Duo, designed for medical use.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb. Their products are listed in the EUDAMED database, FDA’s 510(k) premarket notification system, and FDA’s Unique Device Identifier (UDI) registry. Sedatelec is based in France.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue48

Newest first, rows 1-48 of 48

Search and filter all 48 devices
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  • Module Acuneedle Ref 113549

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • PAL250 Pressure feeler 250g

    Listed Registry: GUDID Class:I

  • EASYO 1 - Multi Pressure Feeler

    Listed Registry: GUDID Class:I

  • Asp ASPTSOLO25

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

  • PAL130 Pressure feeler 130g

    Listed Registry: GUDID Class:I

  • Asp Asptest

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

  • BAT02 Glass rods

    Listed Registry: GUDID Class:I

  • Asp Aspmtest

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

  • PAL400 Pressure feeler 400g

    Listed Registry: GUDID Class:I

  • Asp ASPGSOLO25

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

  • Asp ASPASOLO25

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

  • PAL650 Pressure feeler 650g

    Listed Registry: GUDID Class:I

  • FOREVER NEEDLE REGULAR (1x80) Ref 110488

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • ASP Original GOLD 80 Ref 110625

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • PREMIO 30 EVO Laser Duo Ref 112048

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • APEX Gold 96 Ref 113276

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ASP Original TITANIUM 8 Ref 110638

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Sedatelec Asp Acupuncture Needles Ref K983798

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

  • Dn Acupunture Needles Ref K983800

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

  • Premio 20DT Ref 111672

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • Apex 96 Ref 113275

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • ASP Original GOLD 64 Ref 113209

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Perma-Klick 96 Ref 113281

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • PREMIO 32 EVO laser A-G program Ref 112049

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • PREMIO 32D EVO laser Ref 112685

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • Premio 20D Ref 112802

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • Agistim Duo Ref 108268

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • ASP Original CLASSIC 64 Ref 113208

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Perma-Klick GOLD 96 Ref 113282

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Module Acutrode Ref 113548

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • ASP Original TITANIUM 80 Ref 110626

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Original CLASSIC 200 Ref 110614

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Original CLASSIC 80 Ref 110624

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Multi CLASSIC 120 Ref 113204

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Original TITANIUM 64 Ref 113210

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Multi CLASSIC 320 Ref 113201

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Asp Perma Regular 8 Ref 111181

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • ASP Original TITANIUM 200 Ref 110616

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • PREMIO 10 - Moxa Ref 111237

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

  • ASP Original GOLD 8 Ref 110637

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Premio 40 Light Ref 112953

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • ASP Multi GOLD 320 Ref 113202

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Original CLASSIC 8 Ref 110636

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Multi TITANIUM 120 Ref 113206

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Original GOLD 200 Ref 110615

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Multi GOLD 120 Ref 113205

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • ASP Multi TITANIUM 320 Ref 113203

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

  • Asp Perma Regular 80 Ref 111180

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

Rows 1-48 of 48

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000020946
Other identifier
5711(not a standard FEI format)
DUNS number
266031462
EU VAT number
FR81444273700
EUDAMED status
Active
EUDAMED registered name
Sedatelec
Registered address
Chemin des mûriers, 69540, Irigny, France
Phone
+33 (0) 472 663 322
PRRC contact
Houssem BRAKNI(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 3 Jun 2030

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 015735 0033 Active Supplemented

    Quality management system EU MDR

    Issued
    17 Jun 2026
    Expires
    3 Jun 2030
    Reason
    Add device or group

Frequently asked questions

How many devices does SEDATELEC have in the registry?

The registry currently lists 48 devices for SEDATELEC. Devices recorded under merged duplicate company entries are counted once.

Which registries list SEDATELEC's devices?

Among its 48 most recently registered devices, SEDATELEC has devices listed in EUDAMED (35 devices), FDA 510(k) (2 devices) and FDA GUDID (31 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SEDATELEC's devices fall under?

Among its 48 most recently registered devices, the classes recorded for SEDATELEC's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for SEDATELEC?

EUDAMED lists 1 certificate for SEDATELEC (quality management system) under MDR. The most recent was issued on 17 Jun 2026.

What are the newest devices from SEDATELEC in the registry?

The most recently registered devices listed for SEDATELEC include Module Acuneedle, PAL250 Pressure feeler 250g, EASYO 1 - Multi Pressure Feeler and ASP ASPTSOLO25.

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