Ningbo Huakun Medical Equipment Co., Ltd.

Certificate HZ 2063387-1

Rev. Rev.5Supplemented

Valid until: Dec 29, 2026

Certificate HZ 2063387-1 is a valid Quality management system issued to Ningbo Huakun Medical Equipment Co., Ltd. and registered in EUDAMED. Valid until December 29, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2063387-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 4
Certificate ID: 0197HZ 2063387-1Rev.5

Validity

Issued: Mar 30, 2026
Valid from: Mar 30, 2026
Valid until: Dec 29, 2026

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: No
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: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 2063387-1Quality management systemSupplementedMar 5, 2026 → Dec 29, 2026

Scope coverage

Class IIa2Class I1Class IIb1

4 scopes

R010102 - GUEDEL AIRWAY TUBES R018002 - INTUBATION DEVICE SUPPORTS
Class I
R010201 - LARYNGEAL MASKS R010301 - ENDOTRACHEAL TUBES, CUFFLESS R010302 - ENDOTRACHEAL TUBES, CUFFED R020199 - BREATHING CIRCUITS AND KITS - OTHER R030101 - VENTILATION MASKS R030201 - VENTILATION BALLOONS R030202 - MANUALLY OPERATED VENTILATION BALLOONS
Class IIa
R040199 - VENTILATION FILTERS - OTHER R050102 - CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) R0680 - NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Class IIa
R020107 - RESPIRATORY CIRCUITS AND KITS THERMOREGULATED BREATHING CIRCUITS R060201 - HUMIDIFICATION SYSTEMS ACTIVE VENTILATION HUMIDIFICATION SYSTEMS
Class IIb

Documents

LanguagesEN

Scope coverage

Class IIa2Class I1Class IIb1

4 scopes

R010102 - GUEDEL AIRWAY TUBES R018002 - INTUBATION DEVICE SUPPORTS
Class I
R010201 - LARYNGEAL MASKS R010301 - ENDOTRACHEAL TUBES, CUFFLESS R010302 - ENDOTRACHEAL TUBES, CUFFED R020199 - BREATHING CIRCUITS AND KITS - OTHER R030101 - VENTILATION MASKS R030201 - VENTILATION BALLOONS R030202 - MANUALLY OPERATED VENTILATION BALLOONS
Class IIa
R040199 - VENTILATION FILTERS - OTHER R050102 - CLOSED-CIRCUIT RESPIRATORY SUCTION AND IRRIGATION SYSTEMS (NON-ENDOSCOPIC) R0680 - NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
Class IIa
R020107 - RESPIRATORY CIRCUITS AND KITS THERMOREGULATED BREATHING CIRCUITS R060201 - HUMIDIFICATION SYSTEMS ACTIVE VENTILATION HUMIDIFICATION SYSTEMS
Class IIb

Certificate HZ 2063387-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 2063387-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer