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G22-Gutta Percha Points-GAPA-GIT.06 #15/40

by Tianjin Gapadent Co., Ltd

Ref 06970157004319

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970157004319 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697015700GAPAGPBY Basic UDI-DI 06970157004319UDI-DIDate15 Feb 2023RegisteredStatusActive

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.

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  • Withdrawn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
G22-Gutta Percha Points-GAPA-GIT.06 #15/40 EUDAMED
Gutta Percha Points GUDID
Generic Name
Natural gutta-percha
Model / Reference
06970157004319 EUDAMED
G22-Gutta Percha Points-GAPA-GIT.06 #15/40 GUDID
Primary DI / UDI-DI
06970157004319
Basic UDI-DI
697015700GAPAGPBY
Direct Marketing DI
06970157004319
FDA Product Code
EKM
EMDN Code
Q01010401 Paper and gutta-percha tips, matrices and wedges for dentistry
GMDN Term
Natural gutta-percha
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.3850
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
06970157004319
GUDID
G22-Gutta Percha Points-GAPA-GIT.06 #15/40
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000030044
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Tianjin Gapadent Co., Ltd

See all devices from Tianjin Gapadent Co., Ltd →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No