ANTERION

GUDID 04059237000754

Heidelberg Engineering GmbH

Eye anterior segment analyser
Primary Device ID04059237000754
NIH Device Record Keyec3cc072-ebbd-4e6f-86a6-c4a95d95662f
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTERION
Version Model NumberSoftware with HEYEX 2 V1.2.3
Company DUNS329833875
Company NameHeidelberg Engineering GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104059237000754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-22
Device Publish Date2022-02-14

On-Brand Devices [ANTERION]

0405923700061788036
04059237000754Software with HEYEX 2 V1.2.3
0405923700087788036
04059237000945Software V.1.2.4 US
0405923700093888036

Trademark Results [ANTERION]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANTERION
ANTERION
79222790 5624707 Live/Registered
Heidelberg Engineering GmbH
2017-10-24

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