dermagold100

Organization name

MTS Medical AG (Aktiengesellschaft)

SRN

DE-MF-000005447

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  • Do not direct extracorporeal shock waves onto the unborn child of a pregnant woman! • Do not direct extracorporeal shock waves at tumorous tissue! • Do not direct the focus of shock wave energy on air-filled organs, especially the lungs! • Do not apply medium to high energy (>0.1 mJ / mm2 ) extracorporeal shock waves to the chest and abdominal area! • Do not direct the focus of extracorporeal shock wave energy to the brain! Do not apply medium to high energy (>0.1 mJ / mm2) extracorporeal shock waves to the head! • Do not direct the focus of high energy (≥0.25 mJ / mm2 ) extracorporeal shock waves at epiphyseal plates in children and adolescents! • Do not direct the focus of high energy (≥0.25 mJ / mm2 ) shock waves to large vessels or nerves, especially the spinal cord.

Primary placement in Germany; available across 5 countries total.

Trade name

dermagold100

UDI-DI code

04260484571106

Basic UDI-DI

426048457OW100OW100SZB

Reference / catalog number

1000002

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The dermagold100 is a non-invasive shock wave medical device under the model OW100, which is used together with its accessories for dermatological indications

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12139001SHOCK WAVE THERAPY EQUIPMENT

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification