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Once-Fil Flow 101-2

by Mediclus Co., Ltd

Ref GB2021OC006Model 101-1 Once- Fil Flow Blue, 101-2 Once- Fil Flow Yellow

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880951834TP02NE Basic UDI-DI 08809518340668UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809518340668 UDI-DI Date28 May 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Once-Fil Flow
Generic Name
Dental composite resin
Model / Ref / Catalog
101-1 Once- Fil Flow Blue EUDAMED
101-2 Once- Fil Flow Yellow EUDAMED
GB2021OC006 EUDAMED
101-2 GUDID
EC2501001 GUDID
Primary DI / UDI-DI
08809518340668
Basic UDI-DI
880951834TP02NE
Direct Marketing DI
08809518340668
510(k) Number
FDA Product Code
EBF
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental composite resin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3690
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1.2 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
101-1 Once- Fil Flow Blue, 101-2 Once- Fil Flow Yellow
GB2021OC006
GUDID
101-2
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K251283)

Other devices from MEDICLUS Co., Ltd.

See all devices from MEDICLUS Co., Ltd. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Premarket Exempt: No
  • Serial Number: No