Odyssey iQ OD iQ LTEN 25 D5

by College Park Industries, Inc.

Ref OD iQ LBEN 23 G3, OD iQ RJEN 30 G2, OD iQ RJEN 30 G3Model MYFOOT1988

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number08417471MYFOOT1988AN Basic UDI-DI	Date30 Jul 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00195411454921 UDI-DI	Date26 Oct 2023Listed	StatusListed GUDID: in commercial distribution

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

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Odyssey iQ
Generic Name: Mechatronic external ankle-foot prosthesis
Model / Reference: MYFOOT1988 EUDAMED
OD iQ LBEN 23 G3 EUDAMED
OD iQ RJEN 30 G2 EUDAMED
OD iQ RJEN 30 G3 EUDAMED
OD iQ LTEN 25 D5 GUDID

Primary DI / UDI-DI: 00195411454921 EUDAMED
00195411457663 EUDAMED
00195411457670 EUDAMED
00195411452644 GUDID
Basic UDI-DI: 08417471MYFOOT1988AN
FDA Product Code: ISH
EMDN Code: Y062499 Lower extremity prostheses - other
GMDN Term: Mechatronic external ankle-foot prosthesis

Device Class: Class I
Regulation Number: 890.3420
EU market of registration: Netherlands
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / Reference	EUDAMED MYFOOT1988 OD iQ LBEN 23 G3 OD iQ RJEN 30 G2 OD iQ RJEN 30 G3	GUDID OD iQ LTEN 25 D5
Primary DI / UDI-DI	EUDAMED 00195411454921 00195411457663 00195411457670	GUDID 00195411452644

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Properties

Premarket Exempt
Serial Number
Manufacturing Date

Other properties (21)

Sterile: No
Single Use: 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
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Expiration Date: No