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VELMENI for DENTISTS(V4D)
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref V4D1.0Model 1.0510(k) K250753
by VELMENI Inc.
Identity
- Trade Name
- Velmeni for Dentists FDA UDI
- Generic Name
- Dental x-ray image interpretive software FDA UDI
- Device Name
- VELMENI for DENTISTS(V4D) EUDAMED
- Model / Reference
- 1.0 EUDAMEDFDA UDIV4D1.0 EUDAMED
Identifiers
- Catalog Number
- V4D FDA UDI
- Primary DI / UDI-DI
- 00860010893203 EUDAMEDFDA UDI
- Basic UDI-DI
- 086001089321.0FT EUDAMED
- Direct Marketing DI
- 00860010893203 EUDAMED
- 510(k) Number
- K240003 FDA UDI
- FDA Product Code
- MYN FDA UDI
- EMDN Code
- Z11030392 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Dental x-ray image interpretive software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2070 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VELMENI for DENTISTS(V4D) by Velmeni — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250753 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K240003 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 086001089321.0FT | Class I | Active |
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Manufacturer
- Manufacturer
- VELMENI Inc.
- EUDAMED SRN
- US-MF-000046518
- FDA Applicant
- Velmeni, Inc.
- Authorised Representative
- Freyr Life Sciences GmbH DE-AR-000021795
Sources (3)
- EUDAMED 47b7bb0c-dfa6-4fad-9342-fa88a44d6dd5 85 fields · synced Jun 19, 2026
- FDA UDI 0ed8a8b2-4e76-44df-bd5d-22121474ddae 34 fields · synced May 30, 2026
- FDA 510(k) K250753 1 fields · synced May 18, 2026