EU Manufacturer
๐บ๐ธ United States
Active
Dexcom
SRN: US-MF-000010694
ยท
Sequence Dr 6340, 92121 San Diego, United States
Basic UDI-DIs
12
Total Devices
22
On Market
22
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
17
Basic Information
- Address
- Sequence Dr 6340, 92121 San Diego, United States
- [email protected]
- Phone
- 1-888-738-3646
- Website
- www.dexcom.com
Regulatory Overview
Regulation
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Eu Mdd
11
Eu Mdr
1
Classification
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Eu Md Class 2b
12
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 591560 | BSI Group The Netherlands B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 17 countries across Europe.
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐ฉ๐ช Germany
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE Continuous Glucose Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |
| Dexcom ONE+ CGM System | EU MDR | Eu Md Class 2b | On Market | 0 |