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SpO2 Sensor
EUDAMEDClass IIb (EU MDR)
Ref AMD-RS-AT0002-LRef AMD-RS-AC6501-SRef AMD-RS-NU6528-SRef AMD-RS-AC6519-SRef AMD-RS-ND0001-LRef AMD-RS-AC6513-SRef AMD-RS-AC0033-LRef AMD-RS-AC0060-LRef AMD-RS-PC0001-LRef AMD-RS-AT0001-LRef AMD-RS-AE0001-LRef AMD-RS-AC0001-LRef AMD-RS-NU6501-SRef AMD-RS-PC6502-S
Identity
- Trade Name
- SpO2 Sensor EUDAMED
- Device Name
- Spo2 sensor EUDAMED
- Model / Reference
- AMD-RS-AT0002-L EUDAMEDAMD-RS-AC6501-S EUDAMEDAMD-RS-NU6528-S EUDAMEDAMD-RS-AC6519-S EUDAMEDAMD-RS-ND0001-L EUDAMEDAMD-RS-AC6513-S EUDAMEDAMD-RS-AC0033-L EUDAMEDAMD-RS-AC0060-L EUDAMEDAMD-RS-PC0001-L EUDAMEDAMD-RS-AT0001-L EUDAMEDAMD-RS-AE0001-L EUDAMEDAMD-RS-AC0001-L EUDAMEDAMD-RS-NU6501-S EUDAMEDAMD-RS-PC6502-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931377200967 EUDAMED06931377200011 EUDAMED06931377218030 EUDAMED06931377202817 EUDAMED06931377201995 EUDAMED06931377200042 EUDAMED06931377200868 EUDAMED06931377208666 EUDAMED06931377201988 EUDAMED06931377200677 EUDAMED06931377204804 EUDAMED06931377220316 EUDAMED06931377212403 EUDAMED06931377202572 EUDAMED
- Basic UDI-DI
- B-06931377200967 EUDAMEDB-06931377200011 EUDAMEDB-06931377218030 EUDAMEDB-06931377202817 EUDAMEDB-06931377201995 EUDAMEDB-06931377200042 EUDAMEDB-06931377200868 EUDAMEDB-06931377208666 EUDAMEDB-06931377201988 EUDAMEDB-06931377200677 EUDAMEDB-06931377204804 EUDAMEDB-06931377220316 EUDAMEDB-06931377212403 EUDAMEDB-06931377202572 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMEDZ1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDBelgium EUDAMEDAustria EUDAMEDItaly EUDAMEDDenmark EUDAMEDPoland EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMEDEUDAMED
Reusable
No
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
SpO2 Sensor by Shenzhen Amydi-med Electrics Tech 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-06931377200967 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Amydi-med Electrics Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000013201
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (14)
- EUDAMED 1cecb29d-8969-4af7-b870-eea75ff563b5 61 fields · synced Oct 6, 2026
- EUDAMED 6a33a164-a8e0-486c-b3dd-104f4f0cd096 61 fields · synced May 16, 2026
- EUDAMED b42a230d-c379-4314-8b5e-7adcf266a733 61 fields · synced May 16, 2026
- EUDAMED 7741450e-5474-4652-9640-aae93acda023 61 fields · synced May 17, 2026
- EUDAMED c086ebbd-079e-4aed-a5b7-a501f15ac89a 61 fields · synced May 17, 2026
- EUDAMED cea8e239-0358-43bb-a3b5-2a3ec78ad113 61 fields · synced May 17, 2026
- EUDAMED ae6e4135-9370-4302-8957-e5fb043e16b9 61 fields · synced May 17, 2026
- EUDAMED e16d91ed-90f3-4595-aaf3-39375ddd2475 61 fields · synced May 17, 2026
- EUDAMED f906a8c1-f7e8-433c-865c-8d273e6caf02 61 fields · synced May 18, 2026
- EUDAMED e0284a70-47bd-4ff5-97f6-54f7ec7b271e 61 fields · synced May 18, 2026
- EUDAMED 1e7c4ced-7890-44b9-a239-c7f407eeaec2 61 fields · synced May 18, 2026
- EUDAMED 4c76e56a-d446-4535-ab9b-d19dd849b0c1 61 fields · synced May 18, 2026
- EUDAMED 2918f81b-9c51-47c5-b323-16b9c44bbfd0 61 fields · synced May 18, 2026
- EUDAMED 75ef9d2c-3f56-4bda-9a10-563d6ad39bdd 61 fields · synced May 19, 2026