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Digital Dental X-ray Imaging device

EUDAMED

Class IIb (EU MDR)

Ref -Model Point 800HD 3D PlusModel Point 3D Combi 500Model Point 200HDModel Point 800S HD 3D Plus

by POINTIMPLANT Co., Ltd.

Identity

Trade Name
Digital Dental X-ray Imaging device EUDAMED
Model / Reference
Point 800HD 3D Plus EUDAMED
- EUDAMED
Point 3D Combi 500 EUDAMED
Point 200HD EUDAMED
Point 800S HD 3D Plus EUDAMED

Identifiers

Primary DI / UDI-DI
08800011200091 EUDAMED
08800011200008 EUDAMED
08800011200114 EUDAMED
08800011200107 EUDAMED
Basic UDI-DI
B-08800011200091 EUDAMED
B-08800011200008 EUDAMED
B-08800011200114 EUDAMED
B-08800011200107 EUDAMED
EMDN Code
Z11030302 EUDAMED
Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Portugal EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Digital Dental X-ray Imaging device by POINTIMPLANT Co., Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
POINTIMPLANT Co., Ltd.
EUDAMED SRN
KR-MF-000031947
Authorised Representative
Advena Limited MT-AR-000000234

Sources (7)

  • EUDAMED de7f8fe8-c1a3-4a42-a54e-bd456ac504b2 61 fields · synced Jul 31, 2026
  • EUDAMED c0dbd9c7-2f51-486a-8fc4-838ee12bbdf8 61 fields · synced May 16, 2026
  • EUDAMED d48465e5-611f-4483-874d-d17e33bcd231 61 fields · synced May 17, 2026
  • EUDAMED 88a3359a-9168-4add-9b49-79c06ed70e20 61 fields · synced May 18, 2026
  • EUDAMED c7a3e3c6-1673-41b8-85d0-d44f6f6278b7 61 fields · synced Jul 16, 2026
  • EUDAMED 59559b2f-3b3d-42ab-a171-2a553f3eef21 61 fields · synced Jul 21, 2026
  • EUDAMED 5090f7ae-1efa-430b-b98c-a542c5fb61a4 61 fields · synced Jul 31, 2026