LiNA Medical AG

Certificate HZ 2745863-1

Rev. 1Amended

Valid until: Feb 19, 2031

Certificate HZ 2745863-1 is a valid Quality management system issued to LiNA Medical AG and registered in EUDAMED. Valid until February 19, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2745863-1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2745863-11

Validity

Issued: Jul 8, 2026
Valid from: Jul 8, 2026
Valid until: Feb 19, 2031

Manufacturer

Manufacturer: LiNA Medical AG
Manufacturer SRN: CH-MF-000046832
Manufacturer country: Switzerland

Notified body

Notified body
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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

HZ 2745863-1Quality management systemIssuedJul 7, 2026 → Feb 19, 2031

Scope coverage

Class IIa8Class I4Class IIb4

16 scopes

M040102 - FIXING DRESSINGS
Class I
K02010107 - SMOKE EVACUATION SYSTEMS
Class I
U090399 - SINGLE-USE INSTRUMENTS FOR UROGENITAL ENDOSCOPY – OTHER
Class I
Z12019099 - VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY – OTHER
Class I
K0180 – ENDOTHERAPY DEVICES – OTHER ACCESSORIES.
Class IIa
W0501010280 – CAPILLARY BLOOD COLLECTION DEVICES – ACCESSORIES.
Class IIa
K01020107 – MINIMALLY INVASIVE SURGERY RECOVERY BAGS.
Class IIa
A99 – DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION – OTHER.
Class IIa
A0601010299 – DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION – OTHER.
Class IIa
Z120207 – GENITOURINARY ENDOSCOPY INSTRUMENTS
Class IIa
Z12019099 – VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY – OTHER.
Class IIa
K01010101 – TROCAR STANDARD, SINGLE-USE
Class IIa
K020199 – MONO - AND BIPOLAR DEVICES, SINGLE-USE. MONO - AND BIPOLAR DEVICES, SINGLE USEOTHER.
Class IIb
K02010199 – MONO- AND BIPOLAR DEVICES, SINGLE USE. MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE – OTHER.
Class IIb
K0299 – ELECTROSURGERY DEVICES, SINGLE-USE – OTHER.
Class IIb
Z12080204 – OBSTETRICS AND GYNAECOLOGY INSTRUMENTS. MORCELLATORS.
Class IIb

Documents

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