FEELLIFE HEALTH INC.

Certificate HZ 2139746-1

Rev. Rev.2Supplemented

Valid until: Nov 14, 2029

Certificate HZ 2139746-1 is a valid Quality management system issued to FEELLIFE HEALTH INC. and registered in EUDAMED. Valid until November 14, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2139746-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2139746-1Rev.2

Validity

Issued: Apr 3, 2026
Valid from: Apr 3, 2026
Valid until: Nov 14, 2029

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

HZ 2139746-1Quality management systemSupplementedApr 22, 2025 → Nov 14, 2029

Scope coverage

Class IIa1

1 scope

Products of class IIa: A020104 - SYRINGES FOR INJECTORS, SINGLE-USE A0380 - TUBULAR DEVICES - ACCESSORIES R030102 - AIR/OXYGEN MASKS AND NASAL CANNULAS R030103 - AEROSOL THERAPY MASKS AND SYSTEMS R060101 - COLD NEBULISATION SYSTEMS R0680 - NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES R9001 - RESPIRATORY MOUTHPIECES
Class IIa

Documents

LanguagesEN