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PLS Bundled Set w/NaCL w/Vac

by Haemonetics Corporation

Ref 00627-00Model Plasma Collection Sets with BMB bowl

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 Number081274701PLS0033N Basic UDI-DI 10812747019149UDI-DIDate21 Aug 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  • Withdrawn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

Specification

EUDAMED

Model / Reference
Plasma Collection Sets with BMB bowl, 00627-00
Primary DI / UDI-DI
10812747019149
Basic UDI-DI
081274701PLS0033N
EMDN Code
B030101 Apheresis plasma collection devices
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000034539
Authorised representative
Haemonetics Italia s.r.l IT-AR-000021067

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Sterile
  • CMR Substance
  • Endocrine Disruptor

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No