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Sterile Customized ProcedurePak

by Mölnlycke Health Care AB 598 variants

Ref 97015048-06

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number733243000000000115JS Basic UDI-DI 07313662465715UDI-DIDate8 Jun 2026RegisteredStatusActive

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  • Withdrawn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

EU market availability

Not listed: EUDAMED names no country where this device is made available.

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

Last checked 3 Nov 2026.

Specification

EUDAMED

Device Name
Sterile Customized ProcedurePak
Model / Reference
97015048-06
Primary DI / UDI-DI
07313662465715
Basic UDI-DI
733243000000000115JS
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class III
Medical Purpose
The intention of co-packing components into trays is to replace a large number of individually packaged items and generate savings in time for surgery procedures.

Manufacturer details

EUDAMED SRN
SE-PR-000016902

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Properties

  • Sterile