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Acteon RHL4R M+

by Satelec

Ref F87691

Acteon RHL4R M+ (F87691) is a device classified as Class IIa in the EU and Class II in the US made by Satelec, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI 360982N005am12NX) and listed in FDA GUDID since 4 Aug 2025 (UDI-DI 03609820876917), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number360982N005am12NX Basic UDI-DI 03609820876917UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03609820876917 UDI-DI Date4 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 360982N005am12NX registered 16 Jun 2026 Active
  • FDA GUDID UDI-DI 03609820876917 listed 4 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03609820876917
  2. Registered EUDAMED 360982N005am12NX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
RHL4R M+ EUDAMED
Acteon GUDID
Generic name
Hard/soft-tissue ultrasonic surgical system
Device name
Osteotomy Tips
Model / Ref / Catalog
F87691, RHL4R M+
Primary DI / UDI-DI
03609820876917
Basic UDI-DI
360982N005am12NX
FDA product code
JDX
EMDN code
L0916 Orthopaedic surgery burs and tips, reusable
GMDN term
Hard/soft-tissue ultrasonic surgical system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.4580
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
F87691
GUDID
RHL4R M+
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

Category: Hard/soft-tissue ultrasonic surgical system

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE.

Other devices from Satelec

See all devices from Satelec →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)