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Absorbent Paper Point

by Hubei Guarddent Medical Technology Co., Ltd

Ref 02 taper (15#)Model 02 taper (15#, 20#, 25#, 30#, 35#, 40#, 45#, 50#, 55#, 60#, 70#, 80#, mixed 15#-40#), 04 taper (15#, 20#, 25#, 30#, 35#, 40#), 06 taper (15#, 20#, 25#, 30#, 35#, 40#), F series Protaper (F1, F2, F3, F4, F5)

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697565200APP001FA Basic UDI-DI 06975652002006UDI-DIDate26 Jun 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Absorbent Paper Point
Model / Reference
02 taper (15#, 20#, 25#, 30#, 35#, 40#, 45#, 50#, 55#, 60#, 70#, 80#, mixed 15#-40#), 04 taper (15#, 40#), 06 taper (15#, F series Protaper (F1, F2, F3, F4, F5), 02 taper (15#)
Primary DI / UDI-DI
06975652002006
Basic UDI-DI
697565200APP001FA
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028116
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (13)

  • 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