Eu Mdr
Eu Md Class 2b
On The Market
๐บ๐ธ United States
Dexcom ONE+ CGM System
Devices (same UDI-DI)
11
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 00386270003713
- Basic UDI-DI Code
- 038627D1+CGMKB
- Reference
- STP-D7-001
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Dexcom
Additional Description
Dexcom ONE+ Sensor Kit (EN, ES, SV)
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1204011501 | NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS |
Available In Countries
๐ช๐ธ Spain
๐ฎ๐ช Ireland
๐ธ๐ช Sweden
Related Devices
The Basic UDI-DI associated with this device has 11 devices in total. Below are some other devices sharing the same Basic UDI-DI.
Dexcom ONE+ CGM System
Device
EU MDR
·
Eu Md Class 2b
·Dexcom·On the market·3 countries
Dexcom ONE+ CGM System
Device
EU MDR
·
Eu Md Class 2b
·Dexcom·On the market·4 countries
Dexcom ONE+ CGM System
Device
EU MDR
·
Eu Md Class 2b
·Dexcom·On the market·3 countries
Dexcom ONE+ CGM System
Device
EU MDR
·
Eu Md Class 2b
·Dexcom·On the market·1 country
Dexcom ONE+ CGM System
Device
EU MDR
·
Eu Md Class 2b
·Dexcom·On the market·4 countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).
[TEST ENTRY]-1
Device
EU MDR
·
Eu Md Class 2b
·ResMed PTY LTD·On the market·1 country
HYOT 2700-20-2RD
Device
EU MDR
·
Eu Md Class 2b
·Hytech b.v.·On the market·32 countries
HiRise
Device
EU MDR
·
Eu Md Class 2b
·CurveBeam LLC·On the market·10 countries
InReach
Device
EU MDR
·
Eu Md Class 2b
·CurveBeam LLC·On the market·10 countries
Hemicolectomy left procedure pack
Device
EU MDR
·
Eu Md Class 2b
·On the market
Vivo 1
Device
EU MDR
·
Eu Md Class 2b
·Breas Medical AB·On the market·19 countries