EU Manufacturer
🇺🇸 United States
Active
EPIEN Medical, Inc
SRN: US-MF-000008278
·
White Bear Parkway, Suite 600 4225, 55110 St. Paul, United States
Basic UDI-DIs
3
Total Devices
3
On Market
3
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- White Bear Parkway, Suite 600 4225, 55110 St. Paul, United States
- [email protected]
- Phone
- +1-651-243-7886
- Website
- www.epien.com
Regulatory Overview
Regulation
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Eu Mdr
3
Classification
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Eu Md Class 1
3
Certificate Health
No certificates registered for this manufacturer.
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES | EU MDR | Eu Md Class 1 | On Market | 0 |
| HybenX® OTD | EU MDR | Eu Md Class 1 | On Market | 0 |
| HybenX® OTD Gel | EU MDR | Eu Md Class 1 | On Market | 0 |