Mediworks

FDA UDI

Class II (US FDA UDI)

by Shanghai Mediworks Precision Instruments Co., Ltd.

Identity

Trade Name: Mediworks FDA UDI
Generic Name: Ophthalmic tonometer, manual FDA UDI
Model / Reference: TAT-80T FDA UDI

Identifiers

Primary DI / UDI-DI: 06945087580011 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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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Also classified as Ophthalmic tonometer, manual.

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Cleared under the same submission

K142263 also covers:

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 e68eab6e-e11c-4b90-a9de-36af01600622 33 fields · synced May 30, 2026