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OptimAblate™ Irrigation Pump

by Shanghai MicroPort EP MedTech Co., Ltd.

Ref EPAB 3200

OptimAblate™ Irrigation Pump (EPAB 3200) is a Class IIa device made by Shanghai Microport Ep Medtech Co., Ltd., registered in EUDAMED on 2 Jan 2025 (Basic UDI-DI B-06952450970126), active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06952450970126 Basic UDI-DI 06952450970126UDI-DIDate2 Jan 2025RegisteredStatusActive
European UnionCE/MDD NumberB-06952450970126 Basic UDI-DI 06952450970126UDI-DIDate2 Jan 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade name
OptimAblate™ Irrigation Pump
OptimAblate™ Tubing Set
Model / reference
EPAB 3200
Primary DI / UDI-DI
06952450970126
Basic UDI-DI
B-06952450970126, 69524509C6L01H5
EMDN code
Z12030385, A03040299
Device class
Class IIa
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008518
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Similar devices in this category

Other devices filed under IRRIGATION KITS, SINGLE-USE - OTHER.

Other devices from Shanghai Microport Ep Medtech Co., Ltd.

See all devices from Shanghai Microport Ep Medtech Co., Ltd. →

Properties

  • Supplied sterile
Other properties (13, all answered No)