Enema Bulb

by T2 Corporation Limited Hong Kong EUDAMED

Ref EB-2024-A002, EB-2024-A007, EB-2024-A001, EB-2024-A005, EB-2024-A004, EB-2024-A003

EMDN G02060303

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number5065007341EnemaBulbU2 Basic UDI-DI	Date3 Dec 2024Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: EB-2024-A002, EB-2024-A007, EB-2024-A001, EB-2024-A005, EB-2024-A004, EB-2024-A003

Primary DI / UDI-DI: 05065007341025, 05065007341070, 05065007341018, 05065007341056, 05065007341049, 05065007341032
Basic UDI-DI: 5065007341EnemaBulbU2
EMDN Code: G02060303 Balloon catheters, barium enema

Device Class: Class I
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: HK-MF-000045342
Authorised representative: Kingsmead Service B.V. NL-AR-000002066

Other devices from T2 Corporation Limited

Ear Syringe

Class I
Enema Kit

Class I
Enema Bulb

Class I
Ear Syringe

Class I
Ear Syringe

Class I
Ear Syringe

Class I

Properties & raw data

Show properties, registry sources and raw records

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

Sources (6)

EUDAMED 7367cdfa-6dc2-4c45-a12a-571a25b0d09e 61 fields · synced 22 Oct 2026
EUDAMED 05065007341070|5065007341ENEMABULBU2 61 fields · synced 18 May 2026
EUDAMED 05065007341018|5065007341ENEMABULBU2 61 fields · synced 18 May 2026
EUDAMED 05065007341056|5065007341ENEMABULBU2 61 fields · synced 19 May 2026
EUDAMED 05065007341049|5065007341ENEMABULBU2 61 fields · synced 19 May 2026
EUDAMED 05065007341032|5065007341ENEMABULBU2 61 fields · synced 19 May 2026