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Physiotherapy Apparatus

by BojongMC Co., Ltd.

Ref TF-UM-SP1100Model SP-1100, SP-2100, SP-3100,SP-RB1000, SP-1100E, SP-2100E, SP-3100E, SP-1100WR, SP-1100S, SP-2100S, SP-3100S, SP-1100PS, SP-2100PS, SP-1100P, SP-1100PE, SP-2100P, SP-2100PE

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-08800141400019 Basic UDI-DI 08800141400019UDI-DIDate6 Mar 2024RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
SP-Series
Model / Reference
SP-1100, SP-2100, SP-3100, SP-RB1000, SP-1100E, SP-2100E, SP-3100E, SP-1100WR, SP-1100S, SP-2100S, SP-3100S, SP-1100PS, SP-2100PS, SP-1100P, SP-1100PE, SP-2100P, SP-2100PE, TF-UM-SP1100
Primary DI / UDI-DI
08800141400019
Basic UDI-DI
B-08800141400019
EMDN Code
Z120602 Physiotherapy equipment
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
KR-MF-000026761
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from BojongMC Co., Ltd.

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No