← Back to catalogue
M01dn3, M08dn3, M91dn3n, M127dn3, M49dn3f, M01pdp3, M117dn3, M01da3n, M49dn3, M…
EUDAMEDClass IIb (EU MDR)
Ref REF:M01PDP3 SIZE:M01XDI3-S
Identity
- Device Name
- M01DN3,M08DN3,M91DN3N,M127DN3,M49DN3F,M01PDP3,M117DN3,M01DA3N,M49DN3,M01DP3 EUDAMED
- Model / Reference
- REF:M01PDP3 SIZE:M01XDI3-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977191820202 EUDAMED
- Basic UDI-DI
- 697719182Spo201C6 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
M01dn3, M08dn3, M91dn3n, M127dn3, M49dn3f, M01pdp3, M117dn3, M01da3n, M49dn3, M… by Med Accessories Technology DongGuan Co., Ltd. — Class IIb — MDR — listed…
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 | 697719182Spo201C6 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Med Accessories Technology DongGuan Co., Ltd.
- EUDAMED SRN
- CN-MF-000037840
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 774c6613-0cd8-4d15-b8b6-223a3544a248 61 fields · synced Jun 19, 2026