Sterile Water for Irrig (Plastic Bottle)

by Baxter Healthcare SA 24 variants

Ref TKF7124

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0085412GMN000000000021474 Basic UDI-DI 05413760040981UDI-DI	Date4 Dec 2025Registered	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Withdrawn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/MDR Active

Specification

EUDAMED

Device Name: Sodium Chloride Irrigation
Model / Reference: TKF7124

Primary DI / UDI-DI: 05413760040981
Basic UDI-DI: 0085412GMN000000000021474
EMDN Code: V9099 Various devices not included in other classes - other

Device Class: Class IIb
EU market of registration: Netherlands

Manufacturer details

EUDAMED SRN: CH-MF-000026124
Authorised representative: Baxter Deutschland GmbH DE-AR-000010308

Other devices from Baxter Healthcare SA

GamCath

Class III
Folfusor

Class IIa
Infusor

Class IIa
Clear-Flex

Class IIa
Irrigation Solutions

Class IIb
Tip Cap

Class I

See all devices from Baxter Healthcare SA →

Properties

Sterile

Other properties (12)

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