# Wake Pharma, S.R.O. · 89-08 · CZECH REPUBLIC — FDA import alert red lists: firms subject to detention without physical examination

For Wake Pharma, S.R.O. · 89-08 · CZECH REPUBLIC, import alert is 89-08; 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)"; country is CZECH REPUBLIC; product is Would Be Gone Wound Healing Gel; product code is 79 N - - AE Dressing, Wound, Hydrogel; date published is 11/14/2011; address is Smilovskeho 1264/5 , Praha, CZECH REPUBLIC, verified against its source on 2026-09-16.

- **Firm:** Wake Pharma, S.R.O. _(verified: appears in the quote below)_
- **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:** CZECH REPUBLIC _(verified: appears in the quote below)_
- **Address:** Smilovskeho 1264/5 , Praha, CZECH REPUBLIC _(verified: appears in the quote below)_
- **Date published:** 11/14/2011 _(verified: appears in the quote below)_
- **Product code:** 79 N - - AE Dressing, Wound, Hydrogel _(verified: appears in the quote below)_
- **Product:** Would Be Gone Wound Healing Gel _(verified: appears in the quote below)_
- **FDA notes:** Class I _(verified: appears in the quote below)_

## What the source says

> Wake Pharma, S.R.O. Date Published : 11/14/2011 Smilovskeho 1264/5 , Praha, CZECH REPUBLIC 79 N - - AE Dressing, Wound, Hydrogel Date Published: 11/14/2011 Desc: Would Be Gone Wound Healing Gel Notes: Class I

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).