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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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P.T.S. Haplast - Janusz Hahn

Certificate TNP/MDR/0001/1427/2022

Rev. 1IssuedExpired
Valid until
Sep 12, 2025

Overview

Certificate number
TNP/MDR/0001/1427/2022
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
2274TNP/MDR/0001/1427/20221

Validity

Issued
Sep 13, 2022
Valid from
Sep 14, 2022
Valid until
Sep 12, 2025

Manufacturer

Manufacturer
P.T.S. Haplast - Janusz Hahn
Manufacturer SRN
PL-MF-000023591
Manufacturer country
Poland

Notified body

Notified body
TUV NORD Polska Sp. z o.o
Notified body SRN
2274
Notified body country
Poland

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile
No
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I4

4 scopes

  • Wyroby medyczne z tworzyw sztucznych do podawania leków / Plastic medical devices for drug delivery
    Class I
  • Kieliszek do leków/ Medicine cup
    Class I
  • Łyżeczka do leków/ Spoon for medicines
    Class I
  • Strzykawka doustna/ Oral syringe
    Class I

Documents

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