Physiotherapy Apparatus

EUDAMED

Class I (EU MDR)

Ref TF-UM-SEModel SE-1000Ref 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

by BojongMC Co., Ltd.

Identity

Trade Name: Physiotherapy Apparatus EUDAMED
Device Name: SP-Series EUDAMED
Model / Reference: SE-1000 EUDAMED
TF-UM-SE EUDAMED
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 EUDAMED
TF-UM-SP1100 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800141400118 EUDAMED
08800141400019 EUDAMED
Basic UDI-DI: B-08800141400118 EUDAMED
B-08800141400019 EUDAMED
EMDN Code: Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED

Classification

Device Class: Class I EUDAMED
Class IIa EUDAMED
Market of Registration: Denmark EUDAMED
Romania EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Physiotherapy Apparatus by BojongMC Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-08800141400118	Class I	Active

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Manufacturer

Manufacturer: BojongMC Co., Ltd.
EUDAMED SRN: KR-MF-000026761
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (2)

EUDAMED 0300ed84-d7a9-4105-b197-561086299d96 61 fields · synced Jul 25, 2026
EUDAMED a45f7d9b-0055-4553-877d-115b1b03434d 61 fields · synced May 18, 2026