# Sedatelec

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/sedatelec>
- Country: France (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: FR-MF-000020946
- DUNS: 266031462
- Other registry ID: 5711

## Figures

- Devices: 48
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 35, FDA GUDID 31, FDA 510(k) 2
- Device classes: EU Class IIa 29, FDA Class II 7, FDA Class I 6, EU Class I 3, EU Class IIb 3
- EMDN [A01 Needles](https://devicerts.com/categories/emdn/A01): 25 devices
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 9 devices
- EMDN [V90 Various devices not included in other classes](https://devicerts.com/categories/emdn/V90): 1 devices

## Devices

The first 48 of 48, in the order of the canonical page, which lists them all.

- [Module Acuneedle](https://devicerts.com/devices/module-acuneedle-113549) · ref 113549 · Class I · EUDAMED · status: Active
- [PAL250 Pressure feeler 250g](https://devicerts.com/devices/pal250-pressure-feeler-250g-103304) · Class I · GUDID · status: Listed
- [EASYO 1 - Multi Pressure Feeler](https://devicerts.com/devices/easyo-1-multi-pressure-feeler-112353) · Class I · GUDID · status: Listed
- [Asp ASPTSOLO25](https://devicerts.com/devices/asp-110635) · Class II · GUDID · status: Active
- [PAL130 Pressure feeler 130g](https://devicerts.com/devices/pal130-pressure-feeler-130g-103609) · Class I · GUDID · status: Listed
- [Asp Asptest](https://devicerts.com/devices/asp-110640) · Class II · GUDID · status: Active
- [BAT02 Glass rods](https://devicerts.com/devices/bat02-glass-rods-103607) · Class I · GUDID · status: Listed
- [Asp Aspmtest](https://devicerts.com/devices/asp-113207) · Class II · GUDID · status: Active
- [PAL400 Pressure feeler 400g](https://devicerts.com/devices/pal400-pressure-feeler-400g-103610) · Class I · GUDID · status: Listed
- [Asp ASPGSOLO25](https://devicerts.com/devices/asp-110634) · Class II · GUDID · status: Active
- [Asp ASPASOLO25](https://devicerts.com/devices/asp-110633) · Class II · GUDID · status: Active
- [PAL650 Pressure feeler 650g](https://devicerts.com/devices/pal650-pressure-feeler-650g-103611) · Class I · GUDID · status: Listed
- [FOREVER NEEDLE REGULAR (1x80)](https://devicerts.com/devices/forever-needle-regular-1x80-110488) · ref 110488 · Class IIb · EUDAMED · status: Active
- [ASP Original GOLD 80](https://devicerts.com/devices/asp-original-gold-80-110625) · ref 110625 · Class IIa · EUDAMED, GUDID · status: Active
- [PREMIO 30 EVO Laser Duo](https://devicerts.com/devices/premio-30-evo-laser-duo-112048) · ref 112048 · Class IIa · EUDAMED · status: Active
- [APEX Gold 96](https://devicerts.com/devices/apex-gold-96-113276) · ref 113276 · Class IIa · EUDAMED · status: Active
- [ASP Original TITANIUM 8](https://devicerts.com/devices/asp-original-titanium-8-110638) · ref 110638 · Class IIa · EUDAMED, GUDID · status: Active
- [Sedatelec Asp Acupuncture Needles](https://devicerts.com/devices/sedatelec-asp-acupuncture-needles-mqx) · ref K983798 · Class II · 510(k) · status: Active · decision 1999-08-27
- [Dn Acupunture Needles](https://devicerts.com/devices/dn-acupunture-needles-mqx) · ref K983800 · Class II · 510(k) · status: Active · decision 1999-08-27
- [Premio 20DT](https://devicerts.com/devices/premio-20dt-111672) · ref 111672 · Class IIa · EUDAMED · status: Active
- [Apex 96](https://devicerts.com/devices/apex-96-113275) · ref 113275 · Class IIa · EUDAMED · status: Active
- [ASP Original GOLD 64](https://devicerts.com/devices/asp-original-gold-64-113209) · ref 113209 · Class IIa · EUDAMED, GUDID · status: Active
- [Perma-Klick 96](https://devicerts.com/devices/perma-klick-96-113281) · ref 113281 · Class IIa · EUDAMED · status: Active
- [PREMIO 32 EVO laser A-G program](https://devicerts.com/devices/premio-32-evo-laser-a-g-program-112049) · ref 112049 · Class IIa · EUDAMED · status: Active
- [PREMIO 32D EVO laser](https://devicerts.com/devices/premio-32d-evo-laser-112685) · ref 112685 · Class IIa · EUDAMED · status: Active
- [Premio 20D](https://devicerts.com/devices/premio-20d-112802) · ref 112802 · Class IIa · EUDAMED · status: Active
- [Agistim Duo](https://devicerts.com/devices/agistim-duo-108268) · ref 108268 · Class IIa · EUDAMED · status: Active
- [ASP Original CLASSIC 64](https://devicerts.com/devices/asp-original-classic-64-113208) · ref 113208 · Class IIa · EUDAMED, GUDID · status: Active
- [Perma-Klick GOLD 96](https://devicerts.com/devices/perma-klick-gold-96-113282) · ref 113282 · Class IIa · EUDAMED · status: Active
- [Module Acutrode](https://devicerts.com/devices/module-acutrode-113548) · ref 113548 · Class I · EUDAMED · status: Active
- [ASP Original TITANIUM 80](https://devicerts.com/devices/asp-original-titanium-80-110626) · ref 110626 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Original CLASSIC 200](https://devicerts.com/devices/asp-original-classic-200-110614) · ref 110614 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Original CLASSIC 80](https://devicerts.com/devices/asp-original-classic-80-110624) · ref 110624 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Multi CLASSIC 120](https://devicerts.com/devices/asp-multi-classic-120-113204) · ref 113204 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Original TITANIUM 64](https://devicerts.com/devices/asp-original-titanium-64-113210) · ref 113210 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Multi CLASSIC 320](https://devicerts.com/devices/asp-multi-classic-320-113201) · ref 113201 · Class IIa · EUDAMED, GUDID · status: Active
- [Asp Perma Regular 8](https://devicerts.com/devices/asp-perma-regular-8-111181) · ref 111181 · Class IIb · EUDAMED · status: Active
- [ASP Original TITANIUM 200](https://devicerts.com/devices/asp-original-titanium-200-110616) · ref 110616 · Class IIa · EUDAMED, GUDID · status: Active
- [PREMIO 10 - Moxa](https://devicerts.com/devices/premio-10-moxa-111237) · ref 111237 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Original GOLD 8](https://devicerts.com/devices/asp-original-gold-8-110637) · ref 110637 · Class IIa · EUDAMED, GUDID · status: Active
- [Premio 40 Light](https://devicerts.com/devices/premio-40-light-112953) · ref 112953 · Class I · EUDAMED, GUDID · status: Active
- [ASP Multi GOLD 320](https://devicerts.com/devices/asp-multi-gold-320-113202) · ref 113202 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Original CLASSIC 8](https://devicerts.com/devices/asp-original-classic-8-110636) · ref 110636 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Multi TITANIUM 120](https://devicerts.com/devices/asp-multi-titanium-120-113206) · ref 113206 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Original GOLD 200](https://devicerts.com/devices/asp-original-gold-200-110615) · ref 110615 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Multi GOLD 120](https://devicerts.com/devices/asp-multi-gold-120-113205) · ref 113205 · Class IIa · EUDAMED, GUDID · status: Active
- [ASP Multi TITANIUM 320](https://devicerts.com/devices/asp-multi-titanium-320-113203) · ref 113203 · Class IIa · EUDAMED, GUDID · status: Active
- [Asp Perma Regular 80](https://devicerts.com/devices/asp-perma-regular-80-111180) · ref 111180 · Class IIb · EUDAMED · status: Active

## EU certificates

- G15 015735 0033 · Quality management system · MDR · notified body TÜV SÜD Product Service GmbH · issued 2026-06-17 · expires 2030-06-03 · status: supplemented

## Source and citation

- Cite as: Sedatelec. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/sedatelec (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/sedatelec.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/sedatelec
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.