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Access port

by Shenzhen Edge Medical Co., Ltd.

Ref TR3-AP

Access port (TR3-AP) is a Class IIa device made by Shenzhen Edge Medical Co., Ltd., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 697507099AP000EX), 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 Number697507099AP000EX Basic UDI-DI 06975070999124UDI-DIDate29 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
TR3-AP
Primary DI / UDI-DI
06975070999124
Basic UDI-DI
697507099AP000EX
Unit of use DI
96975070991091
EMDN code
K01020299 Robotic surgery instrument, single-use - other
Device class
Class IIa
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

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE AND ROBOTIC SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Shenzhen Edge Medical Co., Ltd.

See all devices from Shenzhen Edge Medical Co., Ltd. →

Properties

  • Supplied sterile
  • Sterilise before use
Other properties (12, all answered No)