Organization name

STORZ MEDICAL AG

SRN

CH-MF-000014374

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Type B applied part
• Consult instructions for use

Primary placement in Germany; available across 32 countries total.

Trade name

MASTERPULS ONE

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07630039101657

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

76300391ESWT001-SZ

Reference / catalog number

27800.0001

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The MASTERPULS ONE generates radial shockwaves for application in humans. The radial shockwaves are used for treatment of different diseases in the field of orthopedics, urology, and neurology. The method is referred to as extracorporeal shock wave therapy (ESWT).

Additional information URL

http://eifu-storzmedical.com/

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12139001SHOCK WAVE THERAPY EQUIPMENT
• Z120622MUSCLE STIMULATORS
• Z12101106NEUROLOGICAL STIMULATORS
• Z12169002UROLOGICAL STIMULATORS
• Z12169004ERECTILE DYSFUNCTION STIMULATORS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.