Insole

Ref FOOTLAB STABLE TRAC SWEDEN （1200A/1200B/1200E/1200F/1200G/1200）Model FOOTLAB STABLE TRAC SWEDEN （1200A/1200B/1200E/1200F/1200G/1200H ）,FOOTLAB ULTRALITE （21296/21297/21298/21299）,SPENCO DIABETIC INSOLE （226301/226318）

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697882915INSOLE001DM Basic UDI-DI 06978829150005UDI-DI	Date2 Jul 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Insole
Model / Reference: FOOTLAB STABLE TRAC SWEDEN （1200A/1200B/1200E/1200F/1200G/1200H ）, FOOTLAB ULTRALITE （21296/21297/21298/21299）, SPENCO DIABETIC INSOLE （226301/226318）, FOOTLAB STABLE TRAC SWEDEN （1200A/1200B/1200E/1200F/1200G/1200）

Primary DI / UDI-DI: 06978829150005
Basic UDI-DI: 697882915INSOLE001DM
EMDN Code: Y061203 Orthoses, foot (including insoles and inserts)

Device Class: Class I
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000048345
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

Properties

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