Caddie

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref CADDIEModel CADDIE v1.x.x510(k) K240044

by Odin Medical Limited

Identity

Trade Name: CADDIE EUDAMED
Device Name: CADDIE EUDAMED
Model / Reference: CADDIE v1.x.x EUDAMED
CADDIE EUDAMED

Identifiers

Primary DI / UDI-DI: 15065010840000 EUDAMED
Basic UDI-DI: 5065010840OD01P9 EUDAMED
B-15065010840000 EUDAMED
EMDN Code: G99 GASTROINTESTINAL DEVICES - OTHER EUDAMED

Classification

Device Class: Class IIa EUDAMED
Class I EUDAMED
Special Device Type: Software EUDAMED
-1192 EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Caddie by Odin Medical Limited — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K240044	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K252586	Class IIa	Active
EUDAMED	European Union	CE/MDD	5065010840OD01P9	Class IIa	Active
EUDAMED	European Union	CE/MDR	5065010840OD01P9	Class IIa	Active

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Manufacturer

Manufacturer: Odin Medical Limited
EUDAMED SRN: GB-MF-000026653
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (3)

EUDAMED 6f90bfa0-e750-42d4-a839-0932dc673dba 85 fields · synced Jul 9, 2026
EUDAMED fcde7a2a-38ed-4bd0-b021-18de07a0ddc2 61 fields · synced May 17, 2026
FDA 510(k) K240044 1 fields · synced May 18, 2026