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RHL2 M+

by Societe Pour La Conception Des Applications Des Techniques Electroniques

Ref F87694

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number360982N006am12PA Basic UDI-DI 03609820876948UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03609820876948 UDI-DI Date12 Dec 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
RHL2 M+ EUDAMED
Acteon GUDID
Generic Name
Hard/soft-tissue ultrasonic surgical system
Device Name
Osteoplasty Tips
Model / Ref / Catalog
F87694, RHL2
Primary DI / UDI-DI
03609820876948
Basic UDI-DI
360982N006am12PA
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 market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
F87694
GUDID
RHL2
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000004721

Related devices

Category: Fluted surgical drill bit, reusable

Other devices from Societe Pour La Conception Des Applications Des Techniques Electroniques

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No