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REFINE MaxCure9

by Guilin Refine Medical Instrument Co., LTD.

Part of a family of 9 devices: see the family page

Ref MaxCure9Model MaxCure9, MaxCure3, MaxCure5, MaxCure7, MaxCureG, MaxCureH, SWAN, A-Cure, A-Cure Plus, SWAN+

REFINE MaxCure9 is a device classified as Class I in the EU and Class II in the US made by Guilin Refine Medical Instrument Co., LTD., registered in EUDAMED on 8 Oct 2024 (Basic UDI-DI 697156045RCLS8), cleared under FDA 510(k) K223414 on 15 Nov 2023 and listed in FDA GUDID since 22 Nov 2023 (UDI-DI 06971560450786), 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) K223414

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 Number697156045RCLS8 Basic UDI-DI 06971560450786UDI-DIDate8 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06971560450786 UDI-DI Date22 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223414 Date15 Nov 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697156045RCLS8 registered 8 Oct 2024 Active
  • FDA 510(k) K223414 decided 15 Nov 2023 Active
  • FDA GUDID UDI-DI 06971560450786 listed 22 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223414
  2. Listed FDA GUDID 06971560450786
  3. Registered EUDAMED 697156045RCLS8

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  • Withdrawn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
Curing Light EUDAMED
Refine GUDID
Generic name
Dental/surgical polymerization lamp
Model / reference
MaxCure9, MaxCure3, MaxCure5, MaxCure7, MaxCureG, MaxCureH, SWAN, A-Cure, A-Cure Plus, SWAN+
Primary DI / UDI-DI
06971560450786
Basic UDI-DI
697156045RCLS8
Direct marketing DI
06971560450786
510(k) Number
FDA product code
EBZ
EMDN code
Z12119003 Cold light dental equipment
GMDN term
Dental/surgical polymerization lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.6070
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 06971560450786: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Cleared under the same submission (K223414)

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS.

Other devices from Guilin Refine Medical Instrument Co., LTD.

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Serial number
Other properties (23, all answered No)