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PREMIO 10 - Moxa

by Sedatelec

Ref 111237

PREMIO 10 - Moxa (111237) is a musculoskeletal infrared phototherapy unit (EU MDR Class IIa; FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Sedatelec, registered in EUDAMED on 9 Dec 2025 (Basic UDI-DI B-03760262493107), cleared under FDA 510(k) K101267 on 3 Dec 2010 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 03760262493107), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101267↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03760262493107 Basic UDI-DI 03760262493107UDI-DIDate9 Dec 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03760262493107 Basic UDI-DI 03760262493107UDI-DIDate9 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03760262493107 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) 510(k) NumberK101267 Date3 Dec 2010IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760262493107 registered 9 Dec 2025 Active· +1 more in the status table
  • FDA 510(k) K101267 decided 3 Dec 2010 Active
  • FDA GUDID UDI-DI 03760262493107 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101267
  2. Listed FDA GUDID 03760262493107
  3. Registered EUDAMED B-03760262493107

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Musculoskeletal infrared phototherapy unit, non-wearable
Model / Ref / Catalog
111237, PREMIO 10
Primary DI / UDI-DI
03760262493107
Basic UDI-DI
B-03760262493107, 3760262495101YU
510(k) Number
FDA product code
ILY
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Musculoskeletal infrared phototherapy unit, non-wearable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.5500
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
111237
GUDID
PREMIO 10
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FR-MF-000020946

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)