ASTAR spółka z ograniczoną odpowiedzialnością

Certificate HZ 1962094-1

Rev. 1Supplemented

Valid until: Aug 1, 2028

Overview

Certificate number: HZ 1962094-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1962094-11

Validity

Issued: Jun 14, 2024
Valid from: Jun 14, 2024
Valid until: Aug 1, 2028

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: No
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 1962094-1IssuedAug 1, 2023 → Jul 31, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa6Class IIb4

10 scopes

Z120601 - ELECTROTHERAPY EQUIPMENT
Class IIa
Z120602 - PHYSIOTHERAPY EQUIPMENT
Class IIa
Z120606 - MAGNETOTHERAPY EQUIPMENT
Class IIa
Z120610 - ULTRASOUND THERAPY EQUIPMENT
Class IIa
Z120611 - VACUUM THERAPY EQUIPMENT
Class IIa
Z120614 - INFRARED ULTRAVIOLET RAY LAMPS
Class IIa
Z120602 - PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS PHYSIOTHERAPY EQUIPMENT
Class IIb
Z120615 - PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS THERAPEUTIC LASERS
Class IIb
Z120690 - PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS
Class IIb
Z12139001 - ORTHOPEDIC INSTRUMENTS SHOCK WAVE THERAPY EQUIPMENT
Class IIb

Documents

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