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ICamRef
EUDAMEDFDA UDIClass I (EU MDR)
Ref ICR-46-23-14-06-08Model ICamRefRef ICR-46-23-14-08
Identity
- Trade Name
- Imetric FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, reusable FDA UDI
- Device Name
- ICamRef EUDAMEDScanbody FDA UDIICamRef C: MUA Ø 4.6/4.8 - H2.3-M1.4-L6 FDA UDI
- Model / Reference
- ICamRef EUDAMEDICR-46-23-14-06-08 EUDAMEDFDA UDIICR-46-23-14-08 EUDAMEDFDA UDI
- Description
- Scanbody FDA UDIICamRef C: MUA Ø 4.6/4.8 - H2.3-M1.4-L6 FDA UDI
Identifiers
- Catalog Number
- ICR-46-23-14-08 FDA UDIICR-46-23-14-06-08 FDA UDI
- Primary DI / UDI-DI
- 07640243230920 EUDAMEDFDA UDI07640243230531 EUDAMEDFDA UDI
- Basic UDI-DI
- 7640243239311318569T EUDAMED
- Unit of Use DI
- 07640243230937 EUDAMED07640243230586 EUDAMED
- Direct Marketing DI
- 07640243230920 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
ICamRef 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 | 7640243239311318569T | 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 (5)
- EUDAMED a017474f-874f-49c3-a3ca-eb12c716b7bd 61 fields · synced Jul 16, 2026
- FDA UDI 04715997-eb7d-4015-9f89-58f860e66655 35 fields · synced May 30, 2026
- FDA UDI 6164cccf-f265-4728-a635-db926383a57c 35 fields · synced May 30, 2026
- EUDAMED 40f5ef1c-fef8-4497-af65-ab143345102e 61 fields · synced Jun 20, 2026
- EUDAMED 4bb84a6b-27bb-485a-b551-9b03153bd724 61 fields · synced Jul 16, 2026