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Pulse Oximeter
EUDAMEDClass IIa (EU MDR)
Ref MD300C54Model MD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, MD300W628, OX200
Identity
- Trade Name
- Pulse Oximeter EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- MD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, MD300W628, OX200 EUDAMEDMD300C54 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942820421679 EUDAMED
- Basic UDI-DI
- 69428204SPO2VG EUDAMED
- Direct Marketing DI
- 06942820421679 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Pulse Oximeter by Beijing Choice Electronic Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69428204SPO2VG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005776
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 42c76a1a-cd92-4312-9fae-ac71fa4b5602 61 fields · synced May 23, 2026