Suzhou Leapmed Healthcare Corporation

Certificate HZ 2175018-1

Rev. 0Issued

Valid until: Jun 6, 2029

Certificate HZ 2175018-1 is a valid Quality management system issued to Suzhou Leapmed Healthcare Corporation and registered in EUDAMED. Valid until June 6, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2175018-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2175018-10

Validity

Issued: Jun 7, 2024
Valid from: Jun 7, 2024
Valid until: Jun 6, 2029

Manufacturer

Manufacturer: Suzhou Leapmed Healthcare Corporation
Manufacturer SRN: CN-MF-000013964
Manufacturer country: China

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

019013 - PERCUTANEOUS NEEDLES - Disposable Puncture Needles A010201 - NEEDLES AND KITS - HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - Disposable Automatic Core Biopsy Instruments - Disposable Semi Automatic Biopsy Instruments - Disposable Coaxial Biopsy Needles - Disposable Biopsy Refill Needles
Class IIa

Documents

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