Organization name

STORZ MEDICAL AG

SRN

CH-MF-000014374

Manufacturer status

Active

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

• Caution, risk of electric shock
• Consult instructions for use
• Type B applied part

Primary placement in Germany; available across 32 countries total.

Trade name

CELLIMPACT

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.

07630039101695

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.

76300391ESWT006-TG

Reference / catalog number

27100.0100

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The CELLIMPACT generates focused shock waves for application in humans. The shock waves are used for treatment of different diseases in the fields of orthopaedics, urology, neurology and dermatology. 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.

• Z12040203DERMAL REGENERATION EQUIPMENT
• Z12139001SHOCK WAVE THERAPY EQUIPMENT
• Z120622MUSCLE STIMULATORS
• Z12101106NEUROLOGICAL STIMULATORS
• Z12169004ERECTILE DYSFUNCTION STIMULATORS
• Z12169002UROLOGICAL STIMULATORS

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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