Ultramax Products Ltd · 89-08 · UNITED KINGDOM
For Ultramax Products Ltd, import alert is 89-08; country is UNITED KINGDOM; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Penis Pump; product code is 78 L - - KY Device, External Penile Rigidity; date published is 06/15/2010; address is Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Ultramax Products Ltd verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- UNITED KINGDOM verified
- Address
- Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM verified
- Date published
- 06/15/2010 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity verified
- Product
- Penis Pump verified
- FDA notes
- Class III verified
What the source says
Ultramax Products Ltd Date Published : 06/15/2010 Units 4-6 , Malllard Industrial Park , Wakefield, UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
78 L - - KY Device, External Penile Rigidity Date Published: 06/15/2010 Desc: Penis Pump Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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