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Shining 3D® Hacs-Ipg(D60M2-A)

by Shining 3D Tech Co., Ltd.

Ref 0035Model HACS-A15-1，HACS-A15-2，HACS-A15-3，HACS-A15-4，HACS-A15-5，HACS-A20-1，HACS-A20-2，HACS-A20-3，HACS-A20-4，HACS-A20-5，HACS-A25-1，HACS-A25-2，HACS-A25-3，HACS-A25-4，HACS-A25-5

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 Number06942799000035 UDI-DI Date13 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697016308ScanbodyNP Basic UDI-DI 06942799000035UDI-DIDate27 Jun 2024RegisteredStatusActive

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  • Withdrawn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
Hacs-Ipg(D60M2-A) EUDAMED
Shining 3D® GUDID
Generic Name
Dental implant abutment analog, laboratory
Model / Reference
HACS-A15-1，HACS-A15-2，HACS-A15-3，HACS-A15-4，HACS-A15-5，HACS-A20-1，HACS-A20-2，HACS-A20-3，HACS-A20-4，HACS-A20-5，HACS-A25-1，HACS-A25-2，HACS-A25-3，HACS-A25-4，HACS-A25-5 EUDAMED
0035 EUDAMED
HACS-IPG(D60M2-A) GUDID
Primary DI / UDI-DI
06942799000035
Basic UDI-DI
697016308ScanbodyNP
Direct Marketing DI
06942799000035
FDA Product Code
NDP
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental implant abutment analog, laboratory
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Shining 3D Tech Co., Ltd.

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Properties

  • Reusable
  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Lot / Batch Number: No