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Digital Dental X-ray Imaging device
EUDAMEDClass IIb (EU MDR)
Ref -Model Point 3D Combi 500S
Identity
- Trade Name
- Digital Dental X-ray Imaging device EUDAMED
- Model / Reference
- Point 3D Combi 500S EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800011200015 EUDAMED
- Basic UDI-DI
- B-08800011200015 EUDAMED
- EMDN Code
- Z11030302 EUDAMEDZ1103030102 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800011200015 | Class IIb | Active |
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Manufacturer
- Manufacturer
- POINTIMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000031947
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 1fba9c56-0292-41f7-9e4c-a66da7c6e315 61 fields · synced Jun 18, 2026
- EUDAMED c45b8635-6b0d-4493-bce9-63df6a4ec54e 61 fields · synced Jun 18, 2026