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OxiprobE

EUDAMED

Class IIb (EU MDR)

Ref SC01Model BM-536

by Bio Medical Technologies Co., Ltd.

Identity

Trade Name: OxiprobE EUDAMED
Device Name: INFANT DISPOSABLE SENSOR FOR GE OHMEDA EUDAMED
Model / Reference: BM-536 EUDAMED
SC01 EUDAMED

Identifiers

Primary DI / UDI-DI: 08809233905364 EUDAMED
Basic UDI-DI: B-08809233905364 EUDAMED
EMDN Code: C900301 PULSE OXIMETER SENSORS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Pulse oximeter probe, single-use

OxiprobE by Bio Medical Technologies Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, single-use.

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APK — Apk Technology · Class II
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MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: Bio Medical Technologies Co., Ltd.
EUDAMED SRN: KR-MF-000009711
Authorised Representative: CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

EUDAMED 68b9ba2b-b966-49ff-8c2f-135a003e03f2 61 fields · synced May 23, 2026