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E100 series (E1-M +2 more)

FDA UDI

Class I (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name
E100 series(E1-M, E1-C, E1-W) FDA UDI
Generic Name
Fixed examination/treatment room light FDA UDI
Device Name
INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33 FDA UDI
Model / Reference
E1-EB FDA UDI
Description
INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33 FDA UDI

Identifiers

Primary DI / UDI-DI
08800053060790 FDA UDI
FDA Product Code
KZF FDA UDI
GMDN Term
Fixed examination/treatment room light FDA UDI
Models / Variants
E1-M FDA UDI
E1-C FDA UDI
E1-W FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6320 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

Yes

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: Fixed examination/treatment room light

E100 series (E1-M +2 more) by Dentis Co. , Ltd — Class I — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS

Similar devices

Also classified as Fixed examination/treatment room light.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentis Co. , Ltd

Sources (1)

  • FDA UDI da000dc7-3782-478a-8d6b-d4b705915d62 33 fields · synced Jun 1, 2026