Identity
- Trade Name
- ST500 Remote EUDAMEDFDA UDI
- Generic Name
- Ophthalmic tonometer remote control FDA UDI
- Device Name
- ST500 Remote EUDAMEDFDA UDI
- Model / Reference
- TR01 EUDAMEDFDA UDI554 EUDAMED
- Description
- ST500 Remote FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033851807 EUDAMEDFDA UDI
- Basic UDI-DI
- 643003385TR017J EUDAMED
- Direct Marketing DI
- 06430033851807 EUDAMED
- 510(k) Number
- K241447 FDA UDI
- FDA Product Code
- HKX FDA UDIHKY FDA UDI
- EMDN Code
- Z12129080 VARIOUS OPHTALMOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Ophthalmic tonometer remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ST500 Remote by Icare Finland Oy — Class I — 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 | 643003385TR017J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (2)
- EUDAMED bcdcae9f-1f28-49a3-9e96-75f0ed3cd0af 61 fields · synced Jun 19, 2026
- FDA UDI 89153f33-db40-408f-ba31-452a588c9d4f 34 fields · synced May 30, 2026