Identity
- Trade Name
- MediWorks FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Tonometer is indicated for Intraocular Pressure (IOP) measurement . FDA UDI
- Model / Reference
- T170(T) FDA UDI
- Description
- Tonometer is indicated for Intraocular Pressure (IOP) measurement . FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945087517024 FDA UDI
- 510(k) Number
- K142263 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer, manual
MediWorks by Shanghai Mediworks Precision Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Shanghai Mediworks Precision Instruments Co., Ltd.
Sources (1)
- FDA UDI 3139da52-dcbe-4ba2-8602-f3cf2c178cd4 34 fields · synced Jun 8, 2026