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Any-Com Flow

by MEDICLUS Co., Ltd.

Ref GB2206RC001Model 306 Any-Com Flow Kit, 306-1 ~ 306-17 Any-Com Flow Refill, 306-22 ~ 306-26 Any-Com Flow Rainbow, 309 Any-Com Flow Rainbow Kit, 306H Any-Com Flow Kit, 306-1~306-17 Any-Com Flow Refill (A1, A2, A3, A3.5, A4, B1, B2, B3, C2, C3, D2, TL, YTL, RTL, OWT, OA2, OA3), 306-21~306-26 Any-Com Flow Rainbow (Blue, Pink, Purple, Yellow, Green, Orange), 306-8A Any-Com Flow Kit, 309 Any-Com Flow Rainbow Kit, 306 Any-Com Flow Kit510(k) K250823

Any-Com Flow (GB2206RC001) is a medical device (EU MDR Class IIa; EMDN category dental restorative composites) made by MEDICLUS Co., Ltd., registered in EUDAMED on 9 Mar 2026 (Basic UDI-DI B-08809518344178) and cleared under FDA 510(k) K250823 on 14 Apr 2025 (1 earlier submission), active as of 25 Oct 2026.

Active European Union and United States

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250823↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08809518344178 Basic UDI-DI Date9 Mar 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08809518344178 Basic UDI-DI Date9 Mar 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK250823 Date14 Apr 2025ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809518344178 registered 9 Mar 2026 Active· +1 more in the status table
  • FDA 510(k) K250823 decided 14 Apr 2025 Active· +1 more in the status table

Timeline

3 dated events

  1. Cleared FDA 510(k) K241147
  2. Cleared FDA 510(k) K250823
  3. Registered EUDAMED B-08809518344178

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  • Withdrawn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 · 510(k)

Device name
Dental composite resin
Model / reference
306 Any-Com Flow Kit, 306-1 ~ 306-17 Any-Com Flow Refill, 306-22 ~ 306-26 Any-Com Flow Rainbow, 309 Any-Com Flow Rainbow Kit, GB2206RC001, 306H Any-Com Flow Kit, 306-1~306-17 Any-Com Flow Refill (A1, A2, A3, A3.5, A4, B1, B2, B3, C2, C3, D2, TL, YTL, RTL, OWT, OA2, OA3), 306-21~306-26 Any-Com Flow Rainbow (Blue, Pink, Purple, Yellow, Green, Orange), 306-8A Any-Com Flow Kit
Primary DI / UDI-DI
08809518344178, 08809518341085, 08809518340934, 08809518340958, 08809518341115, 08809518341122, 08809518341078, 08809518340941, 08809518340972, 08809518343850, 08809518341023, 08809518340996, 08809518341030, 08809518341016, 08809518341009, 08809518340989, 08809518344680, 08809518341054, 08809518341061, 08809518342228, 08809518342921, 08809518344437, 08809518340965, 08809518344352, 08809518341108, 08809518341047, 08809518341092
Basic UDI-DI
B-08809518344178, 880951834RS17NU, 880951834RS12NJ, 880951834RS18NW, 880951834RS13NL, 880951834RS03NH
Direct marketing DI
08809518344178
08809518341085
08809518340934
08809518340958
08809518341115
08809518341122
08809518341078
08809518340941
08809518340972
08809518343850
08809518341023
08809518340996
08809518341030
08809518341016
08809518341009
08809518340989
08809518344680
08809518341054
08809518341061
08809518342228
08809518342921
08809518344437
08809518340965
08809518344352
08809518341108
08809518341047
08809518341092
EMDN code
Q01010103 Dental restorative composites
Device class
Class IIa
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000022584
Authorised representative
KTR Europe GmbH DE-AR-000005685

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from MEDICLUS Co., Ltd.

See all devices from MEDICLUS Co., Ltd. →

Properties

  • Implantable NoEUDAMEDYesEUDAMED
Other properties (13, all answered No)