Identity
- Trade Name
- MicronMapper Software EUDAMEDMicronMapper FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, laboratory FDA UDI
- Device Name
- MicronMapper EUDAMEDSoftware for MicronMapper and MicronMapper EVO Dental Metrology Systems FDA UDI
- Model / Reference
- 990-MM1-INST-WIN EUDAMEDFDA UDI
- Description
- Software for MicronMapper and MicronMapper EVO Dental Metrology Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209956232 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540209955-ND-MMV3 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental milling system, CAD/CAM, laboratory FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental implant suprastructure, temporary, preformed, single-use
MicronMapper Software by Claronav Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540209955-ND-MMV3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClaroNav Inc.
- EUDAMED SRN
- CA-MF-000028837
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2711fdcc-a487-4dc3-90ab-902a3a72f7be 61 fields · synced Jun 19, 2026
- FDA UDI ae1a80e2-ddd2-4abb-bbcf-e969431bfc8c 33 fields · synced May 30, 2026