Shenzhen Roundwhale Technology Co., Ltd.

Certificate C544552

Rev. 0Issued

Valid until: Jun 27, 2029

Certificate C544552 is a valid Quality management system issued to Shenzhen Roundwhale Technology Co., Ltd. and registered in EUDAMED. Valid until June 27, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: C544552
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5445520

Validity

Issued: Jun 27, 2024
Valid from: Jun 27, 2024
Valid until: Jun 27, 2029

Manufacturer

Manufacturer: Shenzhen Roundwhale Technology Co., Ltd.
Manufacturer SRN: CN-MF-000021504
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Combo Electrotherapy Device
Class IIa
R-C101A, R-C101B, R-C101C, R-C101D, R-C101E, R-C101F, R-C101G, R-C101H, R-C101I, R-C101J, R-C101K, R-C101L, R-C101W, R-C1, R-C1-MEX1, R-C1-SA3, R-C1-RW1, R-C3, R-C4A, R-C4A-AUS1, R-C4A-RW1, R-C4A-RW2, R-C4A-RW3, R-C4A-U12, R-C4B, R-C4B-DE4, R-C4B-RW1, R-C4B-AUS12, R-C4C, R-C4C-AUS1, R-C4D, R-C4D-U7, R-C4D-U9, R-C4D-WH1, R-C4D-RW1, R-E1, R-T1, M100A, M100A-WH1, M101A, M101A-UK1, M101A-WH2, M102A, M103A, M104A, F100, MINI-TENS-COMB, TENS3500
Class IIa

Documents

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