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Basis Flow II

by Yamahachi Dental Mfg., Co. 9 variants

Ref 10KG,V PINK, 650G*500ML,CLEAR, 40G,V PINK, 500G,CLEAR, 40G*20ML,V PINK, 40G*20ML,LF α, 10KG,O PINK, 4L, 40G,LF PINK, 40G*20ML,O PINK, 17L, 40G,CLEAR

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

CE MDD

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/MDD EUDAMED NumberB-XXBF210KGXXVPN Basic UDI-DI Date7 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberXXBF210KGXXVPN UDI-DI Date2 Oct 2023ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Dental appliance fabrication material, resin
Model / Reference
10KG, V PINK, 650G*500ML, CLEAR, 40G, 500G, 40G*20ML, LF α, O PINK, 4L, LF PINK, 17L
Primary DI / UDI-DI
XXBF210KGXXVPN EUDAMED
XXBF26505XXCLE EUDAMED
XXBF2040GXXVPN EUDAMED
XXBF2500GXXCLE EUDAMED
XXBF24020XXVPN EUDAMED
XXBF24020XXLFA EUDAMED
XXBF210KGXXOPN EUDAMED
XXBF2XX4LXXXXX EUDAMED
XXBF2040GXXLFP EUDAMED
XXBF24020XXOPN EUDAMED
XXBF2X17LXXXXX EUDAMED
XXBF2040GXXCLE EUDAMED
D080XXBF26505XXCLE0 GUDID
D080XXBF2500GXXCLE0 GUDID
Basic UDI-DI
B-XXBF210KGXXVPN, B-XXBF26505XXCLE, B-XXBF2040GXXVPN, B-XXBF2500GXXCLE, B-XXBF24020XXVPN, B-XXBF24020XXLFA, B-XXBF210KGXXOPN, B-XXBF2XX4LXXXXX, B-XXBF2040GXXLFP, B-XXBF24020XXOPN, B-XXBF2X17LXXXXX, B-XXBF2040GXXCLE
510(k) Number
FDA Product Code
EBI
EMDN Code
Q0102050199 Dentistry resins - other
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3760
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
XXBF210KGXXVPN
XXBF26505XXCLE
XXBF2040GXXVPN
XXBF2500GXXCLE
XXBF24020XXVPN
XXBF24020XXLFA
XXBF210KGXXOPN
XXBF2XX4LXXXXX
XXBF2040GXXLFP
XXBF24020XXOPN
XXBF2X17LXXXXX
XXBF2040GXXCLE
GUDID
D080XXBF26505XXCLE0
D080XXBF2500GXXCLE0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000024849
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Yamahachi Dental Mfg., Co.

See all devices from Yamahachi Dental Mfg., Co. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: 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
  • Manufacturing Date: No