Identity
- Trade Name
- Mediworks FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- Operation microscope used for observation of surgical and other medical procedures,consisting of an optical system of observation,including objective lens,variable or fixed power optical system,observation tube and eyepieces. FDA UDI
- Model / Reference
- SM610 FDA UDI
- Description
- Operation microscope used for observation of surgical and other medical procedures,consisting of an optical system of observation,including objective lens,variable or fixed power optical system,observation tube and eyepieces. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087561010 FDA UDI
- FDA Product Code
- HRM FDA UDI
- GMDN Term
- General-purpose surgical microscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4700 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose surgical microscope
Mediworks by Shanghai Mediworks Precision Instruments Co., Ltd. — 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
- Shanghai Mediworks Precision Instruments Co., Ltd.
Sources (1)
- FDA UDI cb4e077e-969a-4d4b-a4ae-5b8acbfa2384 33 fields · synced May 30, 2026