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ASP Original TITANIUM 80

by Sedatelec

Ref 110626

ASP Original TITANIUM 80 (110626) is an acupuncture needle (EU MDR Class IIa; FDA Class II; FDA product code MQX, Needle, Acupuncture, Single Use) made by Sedatelec, registered in EUDAMED on 28 Nov 2025 (Basic UDI-DI 3760262490103XV), cleared under FDA 510(k) K060392 on 26 Apr 2006 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 03760262490540), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060392

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3760262490103XV Basic UDI-DI 03760262490540UDI-DIDate28 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number03760262490540 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK060392 Date26 Apr 2006IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3760262490103XV registered 28 Nov 2025 Active
  • FDA 510(k) K060392 decided 26 Apr 2006 Active
  • FDA GUDID UDI-DI 03760262490540 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K060392
  2. Listed FDA GUDID 03760262490540
  3. Registered EUDAMED 3760262490103XV

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ASP Original TITANIUM 80 EUDAMED
Asp GUDID
Generic name
Acupuncture needle, single-use
Model / Ref / Catalog
110626, ASPT80
Primary DI / UDI-DI
03760262490540
Basic UDI-DI
3760262490103XV
510(k) Number
FDA product code
MQX
EMDN code
A019002 Acupuncture needles
GMDN term
Acupuncture needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5580
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
110626
GUDID
ASPT80
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 ACUPUNCTURE NEEDLES.

Other devices from Sedatelec

See all devices from Sedatelec →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)