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Harmony RS
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 06430078740005Ref v3.11.0
Identity
- Trade Name
- Harmony RS EUDAMEDHarmony Referral System FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- Harmony Referral System EUDAMEDHarmony is a web-based software solution that connects all examination instruments, eye care professionals, and the latest technologies to ensure the best possible patient care and customer experience. FDA UDI
- Model / Reference
- 06430078740005 EUDAMEDv3.11.0 EUDAMED3.8.1 FDA UDI
- Description
- Harmony is a web-based software solution that connects all examination instruments, eye care professionals, and the latest technologies to ensure the best possible patient care and customer experience. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430078740005 EUDAMEDFDA UDI06430078740296 EUDAMED
- Basic UDI-DI
- B-06430078740005 EUDAMED6430078740001WW EUDAMED
- 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 I EUDAMEDClass 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Introducing the Harmony RS, a cutting-edge medical device designed for accurate and reliable diagnosis. With its advanced technology and user-friendly interface, this device provides unparalleled results in the ophthalmic field.
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232555 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-06430078740005 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06430078740005 | Class I | Active |
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Manufacturer
- Manufacturer
- Topcon Healthcare Solutions EMEA Oy
- EUDAMED SRN
- FI-MF-000004775
Sources (4)
- EUDAMED 07188b5e-6d34-4c3f-b941-4b716d3475c9 61 fields · synced Aug 1, 2026
- EUDAMED 57c412eb-6035-47de-9fe2-dd4d9ae54764 61 fields · synced May 18, 2026
- FDA UDI e24f6b5e-e926-43ee-819f-817b389fd142 33 fields · synced May 30, 2026
- FDA 510(k) K232555 1 fields · synced May 18, 2026