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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

IS354583-O — Class IIa MDD by Know Medical Srl

MD Atlas
Know Medical Srl

EUDAMED last updated this device on May 28, 2026

IS354583-O

B-IS354583-OGH

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Know Medical Srl
UDI-DI code: D-IS354583-OGH
Reference / catalog number: IS354583-O

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View device family (Basic UDI)

Manufacturer information

Organization name: Know Medical Srl
SRN: IT-MF-000013457
Manufacturer status: Active

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BG150600-OB-08049033191431On the market BG150700-OB-BG150700-OV4On the market FL1 225 OB-08049033196115On the market FL1 410 OB-08049033194463On the market FL1 262 OB-FL1262OKLOn the market

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
EL		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-IS354583-OGH
Basic UDI-DI: B-IS354583-OGH
Reference / catalog number: IS354583-O
Issuing entity: EUDAMED

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: Set somministrazione
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-IS354583-OGH

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

A03010101INFUSION CONTROLLERS WITH OR W/O AIR INLET

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

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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.