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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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Extrudan Sp. z o.o.

Certificate HZ 1949423-1

Rev. 0Issued
Valid until
Jul 14, 2030

Overview

Certificate number
HZ 1949423-1
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0197HZ 1949423-10

Validity

Issued
Jul 15, 2025
Valid from
Jul 15, 2025
Valid until
Jul 14, 2030

Notified body

Notified body
TÜV Rheinland LGA Products GmbH
Notified body SRN
0197
Notified body country
Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
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 IIa8

8 scopes

  • A06010101 - DRAINAGE SYSTEMS WITH PREDEFINED SUCTION
    Class IIa
  • A060102 - SURGICAL DRAINAGE CONNECTION MEDICAL TUBES
    Class IIa
  • K0201011102 - LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY INSTRUMENT KITS, SINGLE-USE
    Class IIa
  • R03010203 - OXYGEN THERAPY NASAL CANNULAS
    Class IIa
  • R05010101 - RESPIRATORY SUCTION PROBES WITHOUT A CONTROL HOLE
    Class IIa
  • R05010102 - RESPIRATORY SUCTION PROBES WITH CONTROL HOLE
    Class IIa
  • U01010502 - NELATON CATHETERS, NON SELF-LUBRICATING
    Class IIa
  • U01010602 - TIEMANN CATHETERS, NON SELF-LUBRICATING
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Extrudan Sp. z o.o.
Manufacturer SRN
PL-MF-000004260
Manufacturer country
Poland