What kind of UDI standards WhaleTeq UDI Management Tool can support?
The WhaleTeq UDI Management Tool support GS1 Standards. GS1 is the most popular UDI Issuing Agency/Entity in the world. GS1 Standards is compliant with worldwide regulations, in particular US, EU, China, South Korea, Saudi Arabia and Taiwan.
| Country | US | EU | Taiwan | China | South Korea |
|---|---|---|---|---|---|
| UDI Issuing Agency |
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How can I use WhaleTeq UDI Management Tool?
Step 1
Please contact
GS1
to get GS1 company prefix code.
Step 2
Please fill the
application form
for WhaleTeq UDI Management Tool and sent email to
service@whaleteq.com
Once we confirm the receipt of your application fee, you company account shall be created accordingly.
Step 3
The activation mail will be sent to your mail box and that shall include the administrator account and password for your company. Please login
UDI Management Tool website
and you may refer to introduction videos on the website for how to use UDI Management Tool.
Can WhaleTeq UDI Management Tool upload data to FDA GUDID database?
Yes, WhaleTeq UDI Management Tool has implemented GUDID third-party submitter using HL7 SPL file submission via FDA Electronic Submissions Gateway. Please use your user account to login and click [Global Database Upload] for uploading your data to FDA GUDID database.
Can WhaleTeq UDI Management Tool meet ISO 13485:2016 requirements?
Yes, we provide UDI procedure and software validation report for the compliance with ISO 13485:2016.
Can I manually download UDI database?
Yes, product UDI history can be selected to download for backup purpose.
If I don’t want to use WhaleTeq UDI Management Tool, will our UDI data still store in the system?
Yes, WhaleTeq UDI Management Tool shall keep all your data for five years. You can download all your data for backup anytime!