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Disposable SpO2 sensor
EUDAMEDClass IIb (EU MDR)
Ref CM-M02-025Model CM-M02-001Ref CM-M02-024Ref CM-M02-027Ref CM-M02-020
Identity
- Trade Name
- Disposable SpO2 sensor EUDAMED
- Device Name
- Reusable SpO2 sensor EUDAMED
- Model / Reference
- CM-M02-001 EUDAMEDCM-M02-025 EUDAMEDCM-M02-024 EUDAMEDCM-M02-027 EUDAMEDCM-M02-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429080810 EUDAMED06945429080803 EUDAMED06945429080834 EUDAMED06945429080766 EUDAMED
- Basic UDI-DI
- 69454290CM005K3 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
Disposable SpO2 sensor by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDR — listed in EUDAMED — 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
- Reusable Soft SpO2 Sensor — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class IIb
- 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69454290CM005K3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 0a837b9d-c6ee-4e22-af2d-16761ab987e6 61 fields · synced Oct 6, 2026
- EUDAMED a983643c-b675-4490-bde5-af3aa92d5aad 61 fields · synced May 17, 2026
- EUDAMED bb4023fd-1701-40c6-8098-08088e38e04d 61 fields · synced May 17, 2026
- EUDAMED 11281f05-348e-47bc-97c6-6827c5dd9a98 61 fields · synced May 17, 2026