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Disposable Spo2 sensors
EUDAMEDClass IIb (EU MDR)
Ref 07-10-00Model Disposable Spo2 sensorsRef 07-10-05Model P0511Model P0511M
Identity
- Trade Name
- Disposable Spo2 sensors EUDAMED
- Device Name
- Disposable Spo2 sensors EUDAMED
- Model / Reference
- Disposable Spo2 sensors EUDAMED07-10-00 EUDAMEDP0511 EUDAMED07-10-05 EUDAMEDP0511M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971556100169 EUDAMED06971556100138 EUDAMED06971556100046 EUDAMED06971556100084 EUDAMED06971556100053 EUDAMED06971556100091 EUDAMED06971556100077 EUDAMED06971556100114 EUDAMED06971556100145 EUDAMED
- Basic UDI-DI
- B-06971556100169 EUDAMEDB-06971556100138 EUDAMEDB-06971556100046 EUDAMEDB-06971556100084 EUDAMEDB-06971556100053 EUDAMEDB-06971556100091 EUDAMEDB-06971556100077 EUDAMEDB-06971556100114 EUDAMEDB-06971556100145 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
Yes
EUDAMEDEUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
Disposable Spo2 sensors by Shenzhen Plinma Technology Co., Ltd — Class IIb — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971556100169 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Plinma Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000022894
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (9)
- EUDAMED c4646904-1b08-49a8-8d98-6f945f0c00b1 61 fields · synced Sep 17, 2026
- EUDAMED a3f0f111-41cf-41ff-8a2d-d3e6ec6d66d5 61 fields · synced May 16, 2026
- EUDAMED b2d6dccb-cfeb-4aaf-adba-0d30be4183f0 61 fields · synced May 17, 2026
- EUDAMED 255653b5-e0be-456f-be5c-c35f7cdca59f 61 fields · synced May 19, 2026
- EUDAMED 89cee86a-abc4-42ad-85d3-ed168cc85e4b 61 fields · synced May 19, 2026
- EUDAMED 7a9bac95-961a-47cc-8685-204ac8144853 61 fields · synced May 19, 2026
- EUDAMED a04e047b-0ebf-4c7c-a0b2-3dd46fd9c4a5 61 fields · synced May 19, 2026
- EUDAMED 3672ff71-11f2-4565-8c12-79873d0d39ea 61 fields · synced May 19, 2026
- EUDAMED 26cc5e0e-d781-4aeb-9a59-b47fa60618f2 61 fields · synced May 19, 2026