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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

QAPL-0001-000 — Class I MDR by Lubelskie Zakłady…

MD Atlas
Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna

EUDAMED last updated this device on Dec 11, 2025

QAPL-0001-000

5906188Aplikatory-kI3U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna
UDI-DI code: 05906188005491
Reference / catalog number: QAPL-0001-000

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Manufacturer information

Organization name: Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna
SRN: PL-MF-000015608
Manufacturer status: Active

Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0024/0052/2024Issued
Quality assuranceNotified body: 2274Expiry: Sep 5, 2027

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: 05906188005491
Basic UDI-DI: 5906188Aplikatory-kI3U
Reference / catalog number: QAPL-0001-000
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: 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

EMDN nomenclature code(s)

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

U0899GYNAECOLOGICAL DEVICES - OTHER

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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