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Agr-Ab

by Shining 3D Tech Co., Ltd.

Part of a family of 15 devices: see the family page

Ref 1193Model Aoralscan Elite

Agr-Ab (1193) is a Class I device made by Shining 3D Tech Co., Ltd., registered in EUDAMED on 13 Jan 2025 (Basic UDI-DI 697016308AoralscanEVR), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697016308AoralscanEVR Basic UDI-DI 06942799001193UDI-DIDate13 Jan 2025RegisteredStatusActive

Official records

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  • Withdrawn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
Intraoral Scanner
Model / reference
Aoralscan Elite, 1193
Primary DI / UDI-DI
06942799001193
Basic UDI-DI
697016308AoralscanEVR
Direct marketing DI
06942799001193
EMDN code
Q0199 Odontology devices - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008402
Authorised representative
Lotus NL B.V. NL-AR-000000121

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

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

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Properties

  • Sterilise before use
Other properties (13, all answered No)