Identity
- Trade Name
- ST500 Adapter EUDAMEDFDA UDI
- Generic Name
- Static ophthalmic equipment stand, manually-adjusted FDA UDI
- Device Name
- ST500 Adapter EUDAMEDFDA UDI
- Model / Reference
- TD01 EUDAMEDFDA UDI556A EUDAMED
- Description
- ST500 Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033851791 EUDAMEDFDA UDI
- Basic UDI-DI
- 643003385TD015C EUDAMED
- 510(k) Number
- K241447 FDA UDI
- FDA Product Code
- HKX FDA UDIHKY FDA UDI
- EMDN Code
- Z12129001 OPHTHALMOLOGICAL INSTRUMENT STANDS EUDAMED
- GMDN Term
- Static ophthalmic equipment stand, manually-adjusted 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 Adapter 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 | 643003385TD015C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (2)
- EUDAMED 7f60dffc-3929-4655-9d54-7c2921000914 61 fields · synced Jul 31, 2026
- FDA UDI 015bbbb8-02fc-44ac-af1f-a61da48146cd 34 fields · synced May 30, 2026