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Intraoral Scanner
EUDAMEDClass I (EU MDR)
Ref /Model FusionScanner SU、FusionScanner SU Lab、FusionScanner SU Pro
Identity
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- FusionScanner SU、FusionScanner SU Lab、FusionScanner SU Pro EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972782481534 EUDAMED06972782481510 EUDAMED06972782481527 EUDAMED
- Basic UDI-DI
- 697278248FSSWQ EUDAMED
- Direct Marketing DI
- 06972782481534 EUDAMED06972782481510 EUDAMED06972782481527 EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental implant suprastructure, temporary, preformed, single-use
Intraoral Scanner by LargeV Instrument Corp., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697278248FSSWQ | Class I | Active |
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Manufacturer
- Manufacturer
- LargeV Instrument Corp., Ltd.
- EUDAMED SRN
- CN-MF-000028675
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (3)
- EUDAMED 37ad4d58-4a5e-4f2e-9238-1475112da2b7 61 fields · synced Jul 24, 2026
- EUDAMED eaffc0b0-c081-49b0-b0d6-b36c206bb825 61 fields · synced May 19, 2026
- EUDAMED 81b4e45c-6dc7-4848-a4bd-b043ab580f00 61 fields · synced May 19, 2026