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Infusionsset Advanced - M1B

by Paul Hartmann AG

Part of a family of 247 devices: see the family page

Ref 4800191Model 3304

Infusionsset Advanced - M1B (4800191) is a Class III device made by Paul Hartmann AG, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 40495003304KC), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number40495003304KC Basic UDI-DI 04052366923727UDI-DIDate26 May 2026RegisteredStatusActive

Official records

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  • Withdrawn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 29 Oct 2026.

Specification

EUDAMED

Device name
Care set Injection / infusion
Model / reference
3304, 4800191
Primary DI / UDI-DI
04052366923727
Basic UDI-DI
40495003304KC
EMDN code
V9099 Various devices not included in other classes - other
Device class
Class III
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
A MediSet is the compilation of defined components used to perform a medical care. The components are single-used products and are used together to perform a medical care.

Manufacturer details

EUDAMED SRN
DE-PR-000019925

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

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Properties

  • Supplied sterile
Other properties (1, all answered No)