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Combo Electrotherapy Device

by Shenzhen Roundwhale Technology Co., Ltd. 137 variants

Ref R-C105AModel R-W100/R-W101/R-W200/R-W201 ( A~E each); R-I100/R-I200/R-I300/R-I400/R-I500/R-I600 (A~E each); R-H100A~E; R-C102/R-C103/R-C104/R-C105/R-C106/R-C108/R-C109/R-C110/R-C111/R-C112 (A~E each); R-C101S

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697176360CE000377 Basic UDI-DI 06971763601343UDI-DIDate27 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
R-W100/R-W101/R-W200/R-W201 ( A~E each), R-I100/R-I200/R-I300/R-I400/R-I500/R-I600 (A~E each), R-H100A~E, R-C102/R-C103/R-C104/R-C105/R-C106/R-C108/R-C109/R-C110/R-C111/R-C112 (A~E each), R-C101S, R-C105A
Primary DI / UDI-DI
06971763601343
Basic UDI-DI
697176360CE000377
Direct Marketing DI
06971763601343
EMDN Code
Z120622 Muscle stimulators
Device Class
Class IIa
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000021504
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Roundwhale Technology Co. Ltd.

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No