Identity
- Trade Name
- IS 3800W I/O 3D Scanner EUDAMEDFDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- IS 3600 I/O 3D Scanner EUDAMED
- Model / Reference
- 5943063 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 5943063 FDA UDI
- Primary DI / UDI-DI
- 00693856000036 EUDAMEDFDA UDI
- Basic UDI-DI
- 0693856IOSGU EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system
IS 3800W I/O 3D Scanner by Dental Imaging Technologies Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0693856IOSGU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Imaging Technologies Corporation
- EUDAMED SRN
- US-MF-000017139
- Authorised Representative
- PaloDEx Group Oy FI-AR-000004955
Sources (2)
- EUDAMED 8e4bed6b-6107-4b82-87f6-d97e93a560ee 61 fields · synced Jul 17, 2026
- FDA UDI 76924168-2eb0-43d3-a7c4-eb33a40b653f 33 fields · synced May 30, 2026