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Kelen Direct

by BTC Pharma s.r.o. Czech Republic EUDAMED

Ref SZ1250002Model Kelen

EMDN M9001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number85940292900209J Basic UDI-DIDate21 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Kelen
Model / Reference
Kelen, SZ1250002
Primary DI / UDI-DI
08594029290051
Basic UDI-DI
85940292900209J
Direct Marketing DI
08594029290051
EMDN Code
M9001 Cryotherapy and thermotherapy devices
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CZ-MF-000025486

Other devices from BTC Pharma s.r.o.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED ec981686-9684-40a3-80c0-81a935b06ef2 61 fields · synced 23 Oct 2026