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Perine Adapter

by Koelis

Ref KRGA.EL5Model Perine Adapter

Perine Adapter (KRGA.EL5) is a device classified as Class I in the EU and Class II in the US made by Koelis, registered in EUDAMED on 25 Oct 2022 (Basic UDI-DI 3665134Adapter_012J), cleared under FDA 510(k) K171040 on 31 Jul 2017 and listed in FDA GUDID since 17 Jul 2020 (UDI-DI 03665134000202), active as of 22 Oct 2026.

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

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) K171040

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 Number3665134Adapter_012J Basic UDI-DI 03665134000202UDI-DIDate25 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number03665134000202 UDI-DI Date17 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171040 Date31 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3665134Adapter_012J registered 25 Oct 2022 Active
  • FDA 510(k) K171040 decided 31 Jul 2017 Active
  • FDA GUDID UDI-DI 03665134000202 listed 17 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K171040
  2. Listed FDA GUDID 03665134000202
  3. Registered EUDAMED 3665134Adapter_012J

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  • Withdrawn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
Perine Adapter EUDAMED
transP - Perine Adaptater GUDID
Generic name
Needle guide, reusable
Model / reference
Perine Adapter, KRGA.EL5
Primary DI / UDI-DI
03665134000202 EUDAMED
03665134000271 GUDID
Basic UDI-DI
3665134Adapter_012J
Direct marketing DI
03665134000202
510(k) Number
FDA product code
ITX
EMDN code
Z11049080 Various ultrasound instruments - hardware accessories
GMDN term
Needle guide, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1570
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
Primary DI / UDI-DIEUDAMED
03665134000202
GUDID
03665134000271
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 03665134000202; FDA GUDID lists 03665134000271), so their flags are not compared. Device class is stated on each registry's own scale: Class I 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-000000830

Similar devices in this category

Other devices filed under VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Koelis

See all devices from Koelis →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)