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Gutta Percha Point

by Chengdu Sani Medical Equipment Co., Ltd. 14 variants

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974242199065 UDI-DI Date14 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697060203GPP0018Z Basic UDI-DI 06974242199065UDI-DIDate9 Oct 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  • Withdrawn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
EXIMIA7
Generic Name
Natural gutta-percha
Device Name
Gutta Percha Point
Model / Ref / Catalog
015/04-H, GPX71504
Primary DI / UDI-DI
06974242199065
Basic UDI-DI
697060203GPP0018Z
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
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000011715
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Chengdu Sani Medical Equipment Co., Ltd

See all devices from Chengdu Sani Medical Equipment 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