DM-850-00

Organization name

INFOMED SA

SRN

CH-MF-000021686

Manufacturer status

Active

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

• CW016

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW999

  DIMI must not be used in the following cases: - For patients weighing less than 20 kg - For all situations described in the medical literature as presenting a potential or real risk to the patient that would be related to devices containing an extracorporeal blood purification circuit and/or any of the intended use of DIMI. - For all situations where the attending physician considers DIMI’s performance inadequate for the patient or when the patient situation is not suitable for the treatment.

Primary placement in France; available across 4 countries total.

Trade name

not provided

UDI-DI code

07640137442767

Basic UDI-DI

B-07640137442767

Reference / catalog number

DM-850-00

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

DIMI machine for at-home dialysis

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• F9099DIALYSIS DEVICES - OTHER

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