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OxiprobE
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref SC01Model BM-470510(k) K132516Model BM-170Model BM-500 OXIMAXModel BM-2070Model BM-100Model BM-300 OXIMAXModel BM-436Model BM-570Model BM-200 OXIMAXModel BM-136Model BM-236Model BM-270Model BM-2010 Model BM-400 OXIMAX
Identity
- Trade Name
- OxiprobE EUDAMED
- Device Name
- PEDIATRIC DISPOSABLE SENSOR FOR NIHON KOHDEN EUDAMEDADULT DISPOSABLE SENSOR FOR NIHON KOHDEN EUDAMEDINFANT DISPOSABLE SENSOR FOR OXIMAX EUDAMEDEXTENSION CABLE FOR NELLCOR EUDAMEDADULT DISPOSABLE SENSOR FOR NELLCOR EUDAMEDReusable Adult sensor for OXIMAX EUDAMEDPEDIATRIC DISPOSABLE SENSOR FOR GE OHMEDA EUDAMEDINFANT DISPOSABLE SENSOR FOR NIHON KOHDEN EUDAMEDADULT/NEONATAL DISPOSABLE SENSOR FOR OXIMAX EUDAMEDADULT DISPOSABLE SENSOR FOR GE OHMEDA EUDAMEDNEONATAL/ADULT DISPOSABLE SENSOR FOR GE OHMEDA EUDAMEDNEONATAL/ADULT DISPOSABLE SENSOR FOR NIHON KOHDEN EUDAMEDEXTENSION CABLE FOR GE EUDAMEDPEDIATRIC DISPOSABLE SENSOR FOR OXIMAX EUDAMED
- Model / Reference
- BM-470 EUDAMEDSC01 EUDAMEDBM-170 EUDAMEDBM-500 OXIMAX EUDAMEDBM-2070 EUDAMEDBM-100 EUDAMEDBM-300 OXIMAX EUDAMEDBM-436 EUDAMEDBM-570 EUDAMEDBM-200 OXIMAX EUDAMEDBM-136 EUDAMEDBM-236 EUDAMEDBM-270 EUDAMEDBM-2010 EUDAMEDBM-400 OXIMAX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809233904701 EUDAMED08809233901700 EUDAMED08809233905012 EUDAMED08809233907047 EUDAMED08809233901007 EUDAMED08809233903018 EUDAMED08809233904367 EUDAMED08809233905708 EUDAMED08809233902011 EUDAMED08809233901366 EUDAMED08809233902363 EUDAMED08809233902707 EUDAMED08809233907016 EUDAMED08809233904015 EUDAMED
- Basic UDI-DI
- B-08809233904701 EUDAMEDB-08809233901700 EUDAMEDB-08809233905012 EUDAMEDB-08809233907047 EUDAMEDB-08809233901007 EUDAMEDB-08809233903018 EUDAMEDB-08809233904367 EUDAMEDB-08809233905708 EUDAMEDB-08809233902011 EUDAMEDB-08809233901366 EUDAMEDB-08809233902363 EUDAMEDB-08809233902707 EUDAMEDB-08809233907016 EUDAMEDB-08809233904015 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMEDZ12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDN01010299,Z12030280 EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Italy EUDAMEDSpain EUDAMEDAustria EUDAMEDGreece 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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter probe, single-use.
- APK — Apk Technology · Class II
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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 (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132516 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809233904701 | Class IIb | Active |
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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 (15)
- EUDAMED 955191bd-01fb-4bf3-964e-82e765a54125 85 fields · synced Sep 17, 2026
- EUDAMED e2b2dad7-8a04-4e25-b974-972bef45f0dd 61 fields · synced May 16, 2026
- EUDAMED 7c31b2a3-0dc0-4fad-ae4c-cdb328ad3ed2 61 fields · synced May 16, 2026
- EUDAMED 69180db3-7dc0-49eb-af2e-935d9a4b14a6 61 fields · synced May 16, 2026
- EUDAMED 6e5a4614-3782-4b9d-b7cb-e893c4b2a189 61 fields · synced May 17, 2026
- EUDAMED 783fb40f-470a-4e3e-beef-fa4703672f8d 61 fields · synced May 17, 2026
- EUDAMED cd90959f-2967-4ac0-b4d0-a5d5e40b4318 61 fields · synced May 17, 2026
- EUDAMED ad0d3306-15af-4ba0-b586-bf4bc74a8478 61 fields · synced May 17, 2026
- EUDAMED 78385d4f-b565-4afb-bdfe-427d168de02f 61 fields · synced Jul 10, 2026
- EUDAMED 8e8dbad5-154f-4ee8-be8f-38f465d4e3cc 61 fields · synced Jul 11, 2026
- EUDAMED 2470e8c1-0954-4d34-80d8-5cb6e56931df 61 fields · synced Jul 19, 2026
- EUDAMED b39ab524-bb4a-4227-942a-f6b118231589 61 fields · synced Jul 27, 2026
- EUDAMED 1f73231c-744a-402f-8c59-9ad2822de1d6 61 fields · synced Jul 28, 2026
- EUDAMED f33e892d-3153-4aea-b1f8-e3a382749465 61 fields · synced Jul 29, 2026
- FDA 510(k) K132516 1 fields · synced May 18, 2026