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First Gel Direct Stick Packs

by Professional Products, Inc. 6 variants

Ref 00230-0610-24Model 200

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08836912008S Basic UDI-DI 08836913464002UDI-DIDate24 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
First Gel Direct Stick Packs
Model / Reference
200, 00230-0610-24
Primary DI / UDI-DI
08836913464002
Basic UDI-DI
08836912008S
EMDN Code
Z12069099 Various physiotherapy and rehabilitation instruments - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000019828
Authorised representative
MDSS GmbH DE-AR-000005430

From the manufacturer

Manufacturer's product page: Hot & Cold Therapy

Other devices from Professional Products, Inc.

See all devices from Professional Products, Inc. →

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