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Pulse Oximeter
EUDAMEDClass IIa (EU MDR)
Ref MD300CI218RModel MD300CI216R, MD300CI218R, MD300CN330R, MD300CN350R, MD300CN356R, MD300W628R
Identity
- Trade Name
- Pulse Oximeter EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- MD300CI216R, MD300CI218R, MD300CN330R, MD300CN350R, MD300CN356R, MD300W628R EUDAMEDMD300CI218R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942820422256 EUDAMED
- Basic UDI-DI
- 69428204SPORXE EUDAMED
- Direct Marketing DI
- 06942820422256 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern 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
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 | 69428204SPORXE | 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 c183dace-a979-4735-b496-95a9b6dd6981 61 fields · synced May 23, 2026