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Emay

FDA UDI

Class II (US FDA UDI)

by Emay (hk) Limited

Identity

Trade Name
Emay FDA UDI
Generic Name
Continuous electronic patient thermometer, battery-powered FDA UDI
Device Name
Electronic Thermometer FDA UDI
Model / Reference
WT2 FDA UDI
Description
Electronic Thermometer FDA UDI

Identifiers

Primary DI / UDI-DI
04897087201019 FDA UDI
510(k) Number
K152739 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Continuous electronic patient thermometer, battery-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Emay by Emay (hk) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Emay (hk) Limited

Sources (1)

  • FDA UDI a89108d0-ab9a-4ec7-9d41-9f781070c628 35 fields · synced Jun 8, 2026