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Snapshot 2026-10-11 · Link to EUDAMED

Combo Electrotherapy Device

UDI-DI 06971763600780Basic UDI-DI 697176360CE000173

Class IIa · MDR · Shenzhen Roundwhale Technology Co., Ltd.

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Identification

Model: R-C1(MEX1/RW1/SA3), R-C3, R-C101A~L/W, R-C4A(AUS1/RW1~RW3/U12), R-C4B(AUS12/DE4/RW1), R-C4C(AUS1), R-C4D(RW1/U7/U9/WH1), R-E1, R-T1, F100, M100A(WH1), M101A(UK1/WH2), M102A, M103A, M104A, MINI-TENS-COMB, TENS3500
EMDN: Z120622
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

Shenzhen Roundwhale Technology Co., Ltd.

SRN CN-MF-000021504

CN · Shenzhen

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

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Canonical device page: /device/combo-electrotherapy-device-0780 · UDI page: /udi/06971763600780

All devices from Shenzhen Roundwhale Technology Co., Ltd.

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