Identity
- Trade Name
- Imetric FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- ICam EUDAMEDICam 5 True Photogrammetry System FDA UDI
- Model / Reference
- ICam EUDAMEDICam-S-5 EUDAMEDFDA UDI
- Description
- ICam 5 True Photogrammetry System FDA UDI
Identifiers
- Catalog Number
- ICam-S-5 FDA UDI
- Primary DI / UDI-DI
- 07640243230913 EUDAMEDFDA UDI
- Basic UDI-DI
- 76402432393113P8 EUDAMED
- Direct Marketing DI
- 07640243230913 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, chairside FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
ICam by Imetric 4D Imaging Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 76402432393113P8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Imetric 4D Imaging Sarl
- EUDAMED SRN
- CH-MF-000048162
- Authorised Representative
- Imetric 4D GmbH DE-AR-000046628
Sources (3)
- EUDAMED 5adc95d8-b79c-4942-a9c7-c5270be9d90d 61 fields · synced Sep 18, 2026
- FDA UDI aa2bf51d-dbd9-43a8-8d74-82d1914c784c 34 fields · synced May 30, 2026
- EUDAMED 7c307b1b-ac52-44bd-b491-0d2732fdf840 61 fields · synced Sep 18, 2026