EU Manufacturer
๐บ๐ธ United States
Active
Insulet Corporation
SRN: US-MF-000007948
ยท
Nagog Park 100, 01720 Acton - Massachusetts, United States
Basic UDI-DIs
13
Total Devices
16
On Market
16
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
17
Basic Information
- Address
- Nagog Park 100, 01720 Acton - Massachusetts, United States
- [email protected]
- Phone
- +19786007825
- Website
- www.omnipod.com
Regulatory Overview
Regulation
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Eu Mdd
12
Eu Mdr
1
Classification
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Eu Md Class 2b
10
Eu Md Class 1
3
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 612985 | BSI Group The Netherlands B.V. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 612985 | BSI Group The Netherlands B.V. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | CE 612985 | BSI Group The Netherlands B.V. | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 612985 | BSI Group The Netherlands B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 17 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Ferring Drug Delivery System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Ferring Drug Delivery System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Omnipod Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Omnipod Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Omnipod Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Omnipod Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Omnipod Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |
| PodPals Adhesive Overlay | EU MDR | Eu Md Class 1 | On Market | 0 |
| PodPals Adhesive Overlay | EU MDR | Eu Md Class 1 | On Market | 0 |
| PodPals Adhesive Overlay | EU MDR | Eu Md Class 1 | On Market | 0 |
| PodPals Adhesive Overlay | EU MDR | Eu Md Class 1 | On Market | 0 |
| PodPals Adhesive Overlay | EU MDD | Eu Md Class 1 | On Market | 1 |
| PodPals Adhesive Overlay | EU MDD | Eu Md Class 1 | On Market | 1 |
| The Omnipod DASH Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |
| The Omnipod DASH Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |
| The Omnipod DASH Insulin Management System | EU MDD | Eu Md Class 2b | On Market | 1 |