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Easyret

by Quantel Medical 2 variants

Ref PABX0041HSSI

Easyret is a device classified as Class IIb in the EU and Class II in the US made by Quantel Medical, registered in EUDAMED on 26 May 2026 (Basic UDI-DI B-03700542625484), cleared under FDA 510(k) K170067 on 25 Jul 2017 and listed in FDA GUDID since 11 Sep 2017 (UDI-DI 03700542625484), active as of 7 Nov 2026.

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

CE MDR 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170067

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03700542625484 Basic UDI-DI 03700542625484UDI-DIDate26 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03700542625484 Basic UDI-DI 03700542625484UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700542625484 UDI-DI Date11 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170067 Date25 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03700542625484 registered 26 May 2026 Active· +1 more in the status table
  • FDA 510(k) K170067 decided 25 Jul 2017 Active
  • FDA GUDID UDI-DI 03700542625484 listed 11 Sep 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170067
  2. Listed FDA GUDID 03700542625484
  3. Registered EUDAMED B-03700542625484

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Easyret EUDAMEDGUDID
EASYRET Haag Streit Type EUDAMED
Generic name
Ophthalmic solid-state laser system
Model / reference
PABX0041HSSI EUDAMED
EASYRET GUDID
Primary DI / UDI-DI
03700542625484
Basic UDI-DI
B-03700542625484, 37005426EASYRETHW
510(k) Number
FDA product code
HQF
EMDN code
Z12011011, Z12120202
GMDN term
Ophthalmic solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4390
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PABX0041HSSI
GUDID
EASYRET
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Ophthalmic solid-state laser system

Cleared under the same submission (K170067)

Similar devices in this category

Other devices filed under LASER SURGERY INSTRUMENTS.

Other devices from Quantel Medical

See all devices from Quantel Medical →

Properties

  • Serial number
Other properties (24, all answered No)