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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

S03N — Class I MDR by P.T.S. Haplast - Janusz…

MD Atlas
P.T.S. Haplast - Janusz Hahn

EUDAMED last updated this device on Nov 18, 2022

S03N

5904870724StrzykawkiFH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: P.T.S. Haplast - Janusz Hahn
UDI-DI code: 05904870724101
Reference / catalog number: S03N

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View device family (Basic UDI)

Manufacturer information

Organization name: P.T.S. Haplast - Janusz Hahn
SRN: PL-MF-000023591
Manufacturer status: Active

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D015904870724KieliszkiYLOn the market D035904870724KieliszkiYLOn the market D055904870724KieliszkiYLOn the market Ł015904870724Lyzeczki9WOn the market Ł025904870724Lyzeczki9WOn the market

Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0040/1427/2025Issued
Quality management systemNotified body: 2274Expiry: Sep 9, 2030
TNP/MDR/0001/1427/2022Issued
Quality management systemNotified body: 2274Expiry: Sep 12, 2025

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: 05904870724101
Basic UDI-DI: 5904870724StrzykawkiFH
Reference / catalog number: S03N
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: 1500
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)05904870724101

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

V0380DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES

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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