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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

3.16 — Class I MDD by Infermedica Sp. z o.o.

MD Atlas
Infermedica Sp. z o.o.

EUDAMED last updated this device on Jul 17, 2024

3.16

B-05904610848005

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Infermedica Sp. z o.o.
UDI-DI code: 05904610848005
Reference / catalog number: 3.16

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View device family (Basic UDI)

Manufacturer information

Organization name: Infermedica Sp. z o.o.
SRN: PL-MF-000030822
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Jul 16, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904610848005
Basic UDI-DI: B-05904610848005
Reference / catalog number: 3.16
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
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

Encoded

(01)05904610848005

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EMDN nomenclature code(s)

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

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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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Related devices

6.5.05904610848MGPB7On the market

Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0039/5172/2025Issued
Quality management systemNotified body: 2274Expiry: Sep 7, 2030