Skip to content

Morpheus8 AG609136A

by Inmode MD, Ltd.

Ref AG609136A

Morpheus8 AG609136A is a device classified as Class IIa in the EU and Class II in the US made by Inmode MD, Ltd., registered in EUDAMED on 28 May 2026 (Basic UDI-DI B-07290016633634), cleared under FDA 510(k) K192695 on 27 Dec 2019 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 07290016633634), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192695

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016633634 Basic UDI-DI 07290016633634UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016633634 UDI-DI Date27 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK192695 Date27 Dec 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016633634 registered 28 May 2026 Active
  • FDA 510(k) K192695 decided 27 Dec 2019 Active
  • FDA GUDID UDI-DI 07290016633634 listed 27 Oct 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192695
  2. Listed FDA GUDID 07290016633634
  3. Registered EUDAMED B-07290016633634

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Morpheus8
Generic name
Radio-frequency skin contouring system applicator tip
Device name
Morpheus8 12 pin Tip
Model / Ref / Catalog
AG609136A
Primary DI / UDI-DI
07290016633634
Basic UDI-DI
B-07290016633634
510(k) Number
FDA product code
GEI
EMDN code
Z12040218 Endermology treatments
GMDN term
Radio-frequency skin contouring system applicator tip
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Cleared under the same submission (K192695)

and 1 more cleared under K192695

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS.

Other devices from Inmode MD, Ltd.

See all devices from Inmode MD, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)