SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság

Certificate 25 0316 QA/NB

Issued

Valid until: Aug 14, 2030

Certificate 25 0316 QA/NB is a valid Quality assurance issued to SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság and registered in EUDAMED. Valid until August 14, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 25 0316 QA/NB
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 102325 0316 QA/NB

Validity

Issued: Aug 15, 2025
Valid from: Aug 15, 2025
Valid until: Aug 14, 2030

Notified body

Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Notified body SRN: 1023
Notified body country: Czechia

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 I91

91 scopes

Reusable surgical and dental hand instruments
Class I
Surgical scissors, reusable
Class I
Scissors for bandages and clothing, reusable
Class I
Surgical sutures scissors, reusable
Class I
Surgical dissection scissors, reusable
Class I
Cardiovascular surgery scissors, reusable
Class I
Ocular enucleation scissors, reusable
Class I
Iris scissors, reusable
Class I
Tonsillar scissors, reusable
Class I
Otolaryngological (ENT) surgery scissors, reusable
Class I
Rectal scissors, reusable
Class I
Gynecology scissors, reusable
Class I
Orthopaedic surgery scissors, reusable
Class I
Surgical scissors, reusable - other
Class I
Surgical saws and blades, reusable
Class I
Manual surgical saws, reusable
Class I
Needles and applicators for ligatures, reusable
Class I
Suture needles, reusable
Class I
Needle holders, reusable
Class I
General surgery surgical cannulas and handpieces, reusable - other
Class I

1 / 5

Documents

LanguagesEN

Scope coverage

Class I91

91 scopes

Reusable surgical and dental hand instruments
Class I
Surgical scissors, reusable
Class I
Scissors for bandages and clothing, reusable
Class I
Surgical sutures scissors, reusable
Class I
Surgical dissection scissors, reusable
Class I
Cardiovascular surgery scissors, reusable
Class I
Ocular enucleation scissors, reusable
Class I
Iris scissors, reusable
Class I
Tonsillar scissors, reusable
Class I
Otolaryngological (ENT) surgery scissors, reusable
Class I
Rectal scissors, reusable
Class I
Gynecology scissors, reusable
Class I
Orthopaedic surgery scissors, reusable
Class I
Surgical scissors, reusable - other
Class I
Surgical saws and blades, reusable
Class I
Manual surgical saws, reusable
Class I
Needles and applicators for ligatures, reusable
Class I
Suture needles, reusable
Class I
Needle holders, reusable
Class I
General surgery surgical cannulas and handpieces, reusable - other
Class I

1 / 5

Certificate 25 0316 QA/NB

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate 25 0316 QA/NB

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer