Eu Mdd
Eu Md Class 2b
On The Market
πΊπΈ United States
Dexcom ONE Continuous Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
11
Notified Bodies
1
Basic Information
- Primary DI
- 00386270001825
- Basic UDI-DI Code
- B-00386270001825
- Reference
- STS-DO-001
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Dexcom
Additional Description
N/A
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1204011585 | INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLEβUSE SENSORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 591560 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
π§πͺ Belgium
π§π¬ Bulgaria
π©πͺ Germany
πͺπͺ Estonia
π¬π· Greece
πͺπΈ Spain
π«π· France
ππ· Croatia
π±πΉ Lithuania
π±π» Latvia
π·π΄ Romania
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e ServiΓ§os Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
Mevion S250i
Device
EU MDD
·
Eu Md Class 2b
·Mevion Medical Systems, Inc.·On the market·1 country