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TandemLoop

by Ovesco Endoscopy AG

Ref 400.15Model TandemLoop

TandemLoop (400.15) is a Class I device made by Ovesco Endoscopy AG, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 426020631SCOPE002DX) with CE/MDR certificate 1000317372 valid until 16 Nov 2030, active as of 13 Nov 2026.

Active European Union

CE MDR

Valid until

16 Nov 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, synced 13 Nov 2026.

Regulatory status

as of registry sync 13 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000317372 Date25 Sep 2026IssuedStatusActive expires 16 Nov 2030

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000317372 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    25 Sep 2026
    Expires
    16 Nov 2030
    Reason
    Change approved

Timeline

3 dated events

  1. Registered EUDAMED 426020631SCOPE002DX
  2. Certificate issued EUDAMED 1000317372
  3. Certificate expires EUDAMED 1000317372

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
TandemLoop, 400.15
Primary DI / UDI-DI
04260206312185
Basic UDI-DI
426020631SCOPE002DX
EMDN code
G03050199 Digestive endoscopy, retrieval devices - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006426

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - OTHER.

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Properties

  • Supplied sterile
Other properties (13, all answered No)