Eu Mdd
Eu Md Class 2a
On The Market
π©πͺ Germany
Scanlight III
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 04250403709000
- Basic UDI-DI Code
- B-04250403709000
- Reference
- AAG120002
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Medset Medizintechnik GmbH
Additional Description
The appropriate use of SCANLIGHT III recorder is 24-hour-blood pressure monitoring and pulse wave analysis (PWA). The SCANLIGHT III recorder should be used only under medical supervision. Because of the risk of strangulation from the tube and cuff, the SCANLIGHT III recorder may not be used for patients who are legally incompetent, and must not get into the hands of unsupervised children. The SCANLIGHT III is not designed for the application in neonates and children under the age of 3. The SCANLIGHT III recorder may not be used for blood pressure monitoring in intensive care or during operation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1203020501 | NONβINVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 50271-16-06 | DEKRA Certification GmbH | Expired |
Available In Countries
π¦πΉ Austria
π¨πΏ Czechia
π©πͺ Germany
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