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OxiprobE

EUDAMED

Class IIb (EU MDR)

Ref SC01Model BM-400

by Bio Medical Technologies Co., Ltd.

Identity

Trade Name: OxiprobE EUDAMED
Device Name: PULSE OXIMETRY SENSOR EUDAMED
Model / Reference: BM-400 EUDAMED
SC01 EUDAMED

Identifiers

Primary DI / UDI-DI: 08809233904008 EUDAMED
Basic UDI-DI: B-08809233904008 EUDAMED
EMDN Code: C900301 PULSE OXIMETER SENSORS EUDAMED

Classification

Device Class: Class IIb EUDAMED
Market of Registration: Spain 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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MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
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M-LNCS — MASIMO CORPORATION · Class II
APK — Apk Technology · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
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 aeb40cb7-4eda-4aa7-be69-0102dae3774a 61 fields · synced May 23, 2026