Identity
- Trade Name
- zumax FDA UDI
- Generic Name
- Retinoscope, line-powered FDA UDI
- Device Name
- Wall Mount streak retinoscope FDA UDI
- Model / Reference
- SR24G FDA UDI
- Description
- Wall Mount streak retinoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945095531302 FDA UDI
- FDA Product Code
- HKL FDA UDI
- GMDN Term
- Retinoscope, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1780 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Retinoscope, line-powered
zumax by Zumax Medical Co., LTD — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Zumax Medical Co., LTD
Sources (1)
- FDA UDI aef03f68-4992-4a52-8d64-2a3d64f8a50d 33 fields · synced Jun 8, 2026