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Remote Data Terminal

by Shenzhen Edge Medical Co., Ltd.

Ref TS0-001

Remote Data Terminal (TS0-001) is a Class IIb device made by Shenzhen Edge Medical Co., Ltd., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 697507099RDT00PM), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697507099RDT00PM Basic UDI-DI 06975070998394UDI-DIDate28 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
TS0-001
Primary DI / UDI-DI
06975070998394
Basic UDI-DI
697507099RDT00PM
Direct marketing DI
06975070998394
EMDN code
Z1202018099 Remote control robot-assisted endoscopic surgery instruments - hardware accessories - other
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000039045
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Other devices filed under REMOTE CONTROL ROBOTIC ENDOSCOPIC SURGERY INSTRUMENTS.

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Properties

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