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Reusable SpO2 Sensor
EUDAMEDClass IIb (EU MDR)
Ref CM-M02-003Model CM-M02-001Ref CM-M02-014Ref CM-M02-007Ref CM-M02-006Ref CM-M02-012Ref CM-M02-010Ref CM-M02-013
Identity
- Trade Name
- Reusable SpO2 Sensor EUDAMED
- Device Name
- Reusable SpO2 sensor EUDAMED
- Model / Reference
- CM-M02-001 EUDAMEDCM-M02-003 EUDAMEDCM-M02-014 EUDAMEDCM-M02-007 EUDAMEDCM-M02-006 EUDAMEDCM-M02-012 EUDAMEDCM-M02-010 EUDAMEDCM-M02-013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429080636 EUDAMED06945429080742 EUDAMED06945429080674 EUDAMED06945429080667 EUDAMED06945429080728 EUDAMED06945429080704 EUDAMED06945429080735 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
Reusable 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
- Spo2 sensor — Orantech Inc. · Class IIb
- 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 (7)
- EUDAMED 8b0986a2-6d43-4425-a2c8-7caf7504b56c 61 fields · synced Jul 31, 2026
- EUDAMED d4b40568-dc9a-45d1-938d-c642f4e5d89d 61 fields · synced May 17, 2026
- EUDAMED 9dce99c1-330f-4329-8bff-6f436b01d2de 61 fields · synced May 18, 2026
- EUDAMED 44f8b2c1-04c9-46d8-8f5c-6d6033642965 61 fields · synced May 18, 2026
- EUDAMED 9eb310fb-4802-4792-b476-b558f1d6a690 61 fields · synced May 19, 2026
- EUDAMED a7df6bc6-cb8e-412f-96c9-e1f324ad1a70 61 fields · synced May 19, 2026
- EUDAMED a3d06f73-6f4f-4b40-a534-e5ce88dcf1c7 61 fields · synced May 19, 2026