Identity
- Trade Name
- Harmony RS EUDAMEDHarmony Referral System FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Harmony Referral System EUDAMED
- Model / Reference
- v3.10.0 EUDAMED3.10.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430078740272 EUDAMEDFDA UDI
- Basic UDI-DI
- 6430078740001WW EUDAMED
- Direct Marketing DI
- 06430078740272 EUDAMED
- 510(k) Number
- K210396 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Harmony RS by Topcon Healthcare Solutions EMEA Oy — Class IIa — 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 | 6430078740001WW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Topcon Healthcare Solutions EMEA Oy
- EUDAMED SRN
- FI-MF-000004775
Sources (2)
- EUDAMED c30f7b74-7c6e-4961-9968-a09a4e179891 61 fields · synced Jun 18, 2026
- FDA UDI de1e9e42-aa9d-4e79-a490-6e2fcd84b8cf 33 fields · synced May 30, 2026