Identity
- Trade Name
- Sunmed FDA UDI
- Generic Name
- Direct ophthalmoscope FDA UDI
- Device Name
- Heine Type X-02.88.085 Opthalmoscope 3 FDA UDI
- Model / Reference
- 5-0239-85 FDA UDI
- Description
- Heine Type X-02.88.085 Opthalmoscope 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483003190 FDA UDI
- FDA Product Code
- HLJ FDA UDI
- GMDN Term
- Direct ophthalmoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sunmed by SunMed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- SunMed
Sources (1)
- FDA UDI debc7c87-4d9d-4601-92a8-d344b379c1ea 36 fields · synced May 30, 2026