Heka

by Allion BV h.o.d.n. van Heek Medical 67 variants

Ref OT0310-2

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number8715886PPHotColdPackRT Basic UDI-DI 08715886028605UDI-DI	Date4 May 2026Registered	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Withdrawn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: Heka cold / hot pack
Model / Reference: OT0310-2

Primary DI / UDI-DI: 08715886028605
Basic UDI-DI: 8715886PPHotColdPackRT
EMDN Code: M9001 Cryotherapy and thermotherapy devices

Device Class: Class I
Medical Purpose: The HEKA cold / hot pack is a reusable cold / hot compress, including protective cover.

Manufacturer details

EUDAMED SRN: NL-PR-000015343

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Properties

Other properties (1)

Sterile: No