Blood/Infusion Warmer

by ELLTEC Co., Ltd.

Ref ANIMEC AM-301-4AF

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-04571370470053 Basic UDI-DI 04571370470053UDI-DI	Date13 May 2026Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name: Blood/Infusion Warmer
Model / Reference: ANIMEC AM-301-4AF

Primary DI / UDI-DI: 04571370470053
Basic UDI-DI: B-04571370470053
EMDN Code: Z12019008 Blood heaters

Device Class: Class IIb
EU market of registration: Norway

Manufacturer details

EUDAMED SRN: JP-MF-000012032
Authorised representative: Obelis s.a. BE-AR-000000106

Other devices from Elltec Co., Ltd.

Animec Am-301-5AF

Class IIb
Modification to Animec, Models Am-2S-4, Am-2S-5, Lt-1-4 & Lt-1-5

Class II
Animec, Models Am-2S-4 and Am-2S-5

Class II

Properties

Measuring Function

Other properties (10)

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