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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

K-2 — Class I MDR by Opharm S.A.

MD Atlas
Opharm S.A.

EUDAMED last updated this device on Jun 3, 2022

K-2

590430208MK201ZJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Opharm S.A.
UDI-DI code: 05904302080638
Reference / catalog number: K-2

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View device family (Basic UDI)

Manufacturer information

Organization name: Opharm S.A.
SRN: PL-MF-000011509
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05904302080638
Basic UDI-DI: 590430208MK201ZJ
Reference / catalog number: K-2
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 2
Additional product description: —
Additional information URL: https://www.opharm.eu/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

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.