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P.T.S. Haplast - Janusz Hahn

Poland PL-MF-000023591 Last updated 17 Sep 2026

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Devices
9
Registries
EUDAMED
FDA recalls
0

Catalogue9

  • S03N Ref S03N

    Class I EUDAMED Active

  • S02 Ref S02

    Class I EUDAMED Active

  • S01 Ref S01

    Class I EUDAMED Active

  • D05 Ref D05

    Class I EUDAMED Active

  • D03 Ref D03

    Class I EUDAMED Active

  • Ł01 Ref Ł01

    Class I EUDAMED Active

  • D01 Ref D01

    Class I EUDAMED Active

  • S03 Ref S03

    Class I EUDAMED Active

  • Ł02 Ref Ł02

    Class I EUDAMED Active

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

TUV NORD Polska Sp. z o.o 2274 2 certificates

  • TNP/MDR/0040/1427/2025 Issued

    Quality assurance EU MDR

    Issued
    18 Sep 2026
    Expires
    9 Sep 2030
  • TNP/MDR/0001/1427/2022 Expired

    Quality management system EU MDR

    Issued
    13 Sep 2022
    Expires
    12 Sep 2025
    Valid from
    14 Sep 2022

Related companies

Notified bodies

What P.T.S. Haplast - Janusz Hahn makes

The company manufactures a range of medical devices primarily used in orthopedic and trauma applications, including surgical implants and fixation systems. These include devices for spinal stabilization (e.g., screws, rods), bone fixation plates, and orthopedic screws for fracture treatment. Additional products appear to include orthopedic screws and fixation hardware for joint surgeries and bone reconstruction.

All listed devices fall under Class I classification in the EU Medical Device Regulation (MDR), and they are registered in the EUDAMED database. The company is based in Poland and adheres to EU regulatory requirements for medical device compliance.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does P.T.S. Haplast - Janusz Hahn manufacture?

P.T.S. Haplast - Janusz Hahn specializes in orthopedic and trauma-related medical devices. Their product range includes surgical implants and fixation systems, such as screws, rods for spinal stabilization, bone fixation plates, and orthopedic screws for fracture treatment. These devices are designed for applications like joint surgeries, bone reconstruction, and trauma stabilization.

Where is P.T.S. Haplast - Janusz Hahn based?

The company is headquartered in Poland, adhering to local and EU regulatory standards for medical device manufacturing and compliance.

Which regulatory registries list the devices manufactured by P.T.S. Haplast - Janusz Hahn?

The company’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This platform tracks devices authorized under EU regulations, including those classified under the MDR.

How are the devices from P.T.S. Haplast - Janusz Hahn classified under EU regulations?

All devices produced by P.T.S. Haplast - Janusz Hahn fall under Class I classification in the EU Medical Device Regulation (MDR). This classification applies to low-risk devices, such as some orthopedic fixation systems and implants, where the risk to patient safety is minimal and conformity assessment procedures are streamlined.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Poland
Address
9, Olsztyńska, Wrocław, Poland
Website
haplast.pl
PRRC contact
Milena Gołębiewska
EUDAMED SRN
PL-MF-000023591