Identity
- Trade Name
- Harmony Referral System FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Model / Reference
- 3.9.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430078740265 FDA UDI
- 510(k) Number
- K210396 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical image management system
Harmony Referral System by Topcon Healthcare Solutions EMEA Oy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Topcon Healthcare Solutions EMEA Oy
Sources (1)
- FDA UDI 99f2649c-61f4-42b5-ba0e-faae919fc2c1 33 fields · synced Jun 8, 2026