Skip to content

SuctionBook1.1

by ACOMA Medical Industry Co., Ltd.

Ref QI：4.58-F13_enModel SuctionBook

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, self-declared

Class I: no certifier involved

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 Number458213536AC0001RW Basic UDI-DI 04582135367365UDI-DIDate24 Sep 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
SuctionBook1.1 Sakura pink
Model / Reference
SuctionBook, QI：4.58-F13_en
Primary DI / UDI-DI
04582135367365
Basic UDI-DI
458213536AC0001RW
EMDN Code
A0601010201 Drainage systems with adjustable suction and collection chamber
Device Class
Class I

Manufacturer details

EUDAMED SRN
JP-MF-000059145
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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