Organization name

Shenzhen Roundwhale Technology Co., Ltd.

SRN

CN-MF-000021504

Manufacturer status

Active

Primary placement in Sweden; available across 32 countries total.

Trade name

Combo Electrotherapy Device

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.

06971763600643

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.

697176360CE000173

Reference / catalog number

M104A

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 device is designed to be used for temporary relief of pain, including the acute and chronic pain relief. The device is designed to be used for stimulate muscles for prevention of muscular atrophy, muscle strengthening and improve ，Increasing local blood circulation and facilitate muscle performance.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z120622MUSCLE STIMULATORS

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.