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OP-Set

by Rosa Toifl & Co GmbH 12 variants

Ref 5000

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9010845OP-Set-WW Basic UDI-DI 09010845000012UDI-DIDate20 Dec 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
OP-Set
Model / Reference
5000
Primary DI / UDI-DI
09010845000012
Basic UDI-DI
9010845OP-Set-WW
Direct Marketing DI
09010845000012
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000020516

Other devices from Rosa Toifl & Co GmbH

See all devices from Rosa Toifl & Co GmbH →

Properties

  • Sterile
  • Reprocessed

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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