Taian Dalu Medical Instrument Co., Ltd.

Certificate DZ 2183264-1

Rev. Rev.3Supplemented

Valid until: Apr 20, 2028

Certificate DZ 2183264-1 is a valid Quality assurance issued to Taian Dalu Medical Instrument Co., Ltd. and registered in EUDAMED. Valid until April 20, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: DZ 2183264-1
Certificate type: Quality assurance
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197DZ 2183264-1Rev.3

Validity

Issued: Apr 13, 2026
Valid from: Apr 13, 2026
Valid until: Apr 20, 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: No
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: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

DZ 2183264-1Quality assuranceReissuedApr 21, 2025 → Apr 20, 2028

Scope coverage

Class I1Class IIa1

2 scopes

Z121501- SPIROMETRY INSTRUMENTS
Class I
R030103 - AEROSOL THERAPY MASKS AND SYSTEMS R060101 - COLD NEBULISATION SYSTEMS R049001 - PULMONARY FUNCTION TEST FILTERS Z121501 - SPIROMETRY INSTRUMENTS
Class IIa

Documents

LanguagesEN