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by Aidite（Qinhuangdao）Technology Co., Ltd. 3 variants

Ref 40×15×19-SHT-PlusModel COLOR, STC, SHTPC, SHT-Plus

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

CE MDR CE MDD

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
European UnionCE/MDD EUDAMED Number697645949ZCCZW Basic UDI-DI Date28 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number697645949ZCCZW Basic UDI-DI Date28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06976459498672 UDI-DI Date17 Nov 2025ListedStatusListed 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
En EUDAMED
Dental Zirconia Ceramic EUDAMED
Aidite GUDID
Generic Name
Dental appliance fabrication material, ceramic
Model / Reference
COLOR, STC, SHTPC, SHT-Plus, 40×15×19-SHT-Plus
Primary DI / UDI-DI
06976459498672, 06978447938429, 06975347289996, 06975347287985, 06975347287992, 06978447938467, 06979046192663, 06975347288005, 06976459498740, 06976459498634, 06975347287978, 06976459498733, 06976459498641, 06979046191956, 06976087537088, 06975347289989
Basic UDI-DI
697645949ZCCZW, B-06976459498733, B-06976459498641, B-06978447938429, B-06975347287978, B-06976459498634, B-06975347289996, B-06976459498740, B-06976087537088, B-06975347287992, B-06978447938467, B-06976459498672, B-06975347289989, B-06979046192663, B-06975347287985, B-06975347288005, B-06979046191956
FDA Product Code
EIH
EMDN Code
Q01010101, Q01010199
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
COLOR, STC, SHTPC, SHT-Plus
40×15×19-SHT-Plus
GUDID
SHT-Plus
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000015573
Authorised representative
AIDITE Europe GmbH DE-AR-000048785

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Properties

  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No