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Obturator

by Shenzhen Edge Medical Co., Ltd. 2 variants

Ref TR2-SP

Obturator (TR2-SP) is a Class I device made by Shenzhen Edge Medical Co., Ltd., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 697507099o0001NB), 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 Number697507099o0001NB Basic UDI-DI Date1 Jun 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
TR2-SP
Primary DI / UDI-DI
06975070996253, 06942854303095
Basic UDI-DI
697507099o0001NB
EMDN code
L1399 Robotic surgery instruments, reusable - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

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 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Shenzhen Edge Medical Co., Ltd.

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

Properties

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