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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

IDROSTAR PRO PULSE — Class IIa MDD by Laboratoires I2M

MD Atlas
Laboratoires I2M

EUDAMED last updated this device on Dec 15, 2024

IDROSTAR PRO PULSE

B-03760175710117

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laboratoires I2M
UDI-DI code: 03760175710117
Reference / catalog number: IDROSTAR PRO PULSE

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Manufacturer information

Organization name: Laboratoires I2M
SRN: FR-MF-000000296
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 1987	Still on market
XI	Jan 1, 1987	Still on market

Device identification

Trade name: IDROSTAR PRO PULSE
UDI-DI code: 03760175710117
Basic UDI-DI: B-03760175710117
Reference / catalog number: IDROSTAR PRO PULSE
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: IONTOPHORESIS EQUIPMENT
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120604IONTOPHORESIS EQUIPMENT

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

I2M.AB-03760175710025On the market IDROSTARB-03760175710018On the market IDROSTAR AXILLAB-03760175710070On the market IDROSTAR NTB-03760175710087On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.