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Pulse Oximeter
EUDAMEDClass IIa (EU MDR)
Ref MD300C21Model MD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, OX200Ref MD300CN330RModel MD300CI216R, MD300CI218R, MD300CN330R, MD300CN350R, MD300CN356RRef MD300CN140Ref MD300CN360Ref MD300C23Ref MD300C41Ref PX-101Ref MD300C29Ref MD300W628Model MD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, MD300W628, OX200Ref MD300CN130Ref P300 Intelli IT(HPO-300T)Ref OXY300Ref MD300C53Ref MD300CN160Ref MD300C55Ref MD300CN150Ref MD300C208Ref MD300CN350RRef MD300MNRRef MD300CN356Ref MD300C13Ref MD300CN330Ref MD300C19Ref MD300CN310Ref OX200Ref MD300C2Ref MD300CI218Ref MD300K2NModel MD300W seriesRef MD300CN340Ref MD300C26Ref MD300C52Ref MD300CI218RRef MD300C5Ref MD300C203Ref MD300C54Ref MD300C22
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, OX200 EUDAMEDMD300C21 EUDAMEDMD300CI216R, MD300CI218R, MD300CN330R, MD300CN350R, MD300CN356R EUDAMEDMD300CN330R EUDAMEDMD300CN140 EUDAMEDMD300CN360 EUDAMEDMD300C23 EUDAMEDMD300C41 EUDAMEDPX-101 EUDAMEDMD300C29 EUDAMEDMD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, MD300W628, OX200 EUDAMEDMD300W628 EUDAMEDMD300CN130 EUDAMEDP300 Intelli IT(HPO-300T) EUDAMEDOXY300 EUDAMEDMD300C53 EUDAMEDMD300CN160 EUDAMEDMD300C55 EUDAMEDMD300CN150 EUDAMEDMD300C208 EUDAMEDMD300CN350R EUDAMEDMD300MNR EUDAMEDMD300CN356 EUDAMEDMD300C13 EUDAMEDMD300CN330 EUDAMEDMD300C19 EUDAMEDMD300CN310 EUDAMEDOX200 EUDAMEDMD300C2 EUDAMEDMD300CI218 EUDAMEDMD300K2N EUDAMEDMD300W series EUDAMEDMD300CN340 EUDAMEDMD300C26 EUDAMEDMD300C52 EUDAMEDMD300CI218R EUDAMEDMD300C5 EUDAMEDMD300C203 EUDAMEDMD300C54 EUDAMEDMD300C22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942820421785 EUDAMED06942820422232 EUDAMED06942820421525 EUDAMED06942820421600 EUDAMED06942820421754 EUDAMED06942820421716 EUDAMED06942820421631 EUDAMED06942820421778 EUDAMED06942820421846 EUDAMED06942820421518 EUDAMED06942820421402 EUDAMED06942820422393 EUDAMED06942820421662 EUDAMED06942820421549 EUDAMED06942820421686 EUDAMED06942820421532 EUDAMED06942820421808 EUDAMED06942820421877 EUDAMED06942820422027 EUDAMED06942820421624 EUDAMED16942820420204 EUDAMED06942820422249 EUDAMED06942820420245 EUDAMED06942820420108 EUDAMED06942820421945 EUDAMED06942820421976 EUDAMED06942820421471 EUDAMED06942820421457 EUDAMED06942820420269 EUDAMED06942820420023 EUDAMED06942820421334 EUDAMED06942820421952 EUDAMED06942820421440 EUDAMED06942820420078 EUDAMED06942820420306 EUDAMED06942820421938 EUDAMED06942820422034 EUDAMED06942820421419 EUDAMED06942820422416 EUDAMED06942820420276 EUDAMED16942820420099 EUDAMED06942820420016 EUDAMED06942820422164 EUDAMED06942820420535 EUDAMED06942820420030 EUDAMED06942820421389 EUDAMED06942820420610 EUDAMED26942820422397 EUDAMED06942820420450 EUDAMED06942820420511 EUDAMED06942820420221 EUDAMED06942820421983 EUDAMED06942820420238 EUDAMED16942820422390 EUDAMED06942820420627 EUDAMED06942820422300 EUDAMED06942820420313 EUDAMED06942820420474 EUDAMED06942820421181 EUDAMED06942820421747 EUDAMED06942820420665 EUDAMED06942820421839 EUDAMED
- Basic UDI-DI
- 69428204SPO2VG EUDAMED69428204SPORXE EUDAMEDB-06942820422393 EUDAMED69428204SPBRW7 EUDAMEDB-16942820420204 EUDAMEDB-06942820420245 EUDAMEDB-06942820420108 EUDAMEDB-06942820421945 EUDAMEDB-06942820421976 EUDAMEDB-06942820421471 EUDAMEDB-06942820421457 EUDAMEDB-06942820420269 EUDAMEDB-06942820420023 EUDAMEDB-06942820421334 EUDAMEDB-06942820421952 EUDAMEDB-06942820421440 EUDAMEDB-06942820420078 EUDAMEDB-06942820420306 EUDAMEDB-06942820421938 EUDAMED69428204SPOBWE EUDAMEDB-06942820421419 EUDAMED69428204SPOWXQ EUDAMEDB-06942820420276 EUDAMEDB-16942820420099 EUDAMEDB-06942820420016 EUDAMEDB-06942820422164 EUDAMEDB-06942820420535 EUDAMEDB-06942820420030 EUDAMEDB-06942820420610 EUDAMEDB-26942820422397 EUDAMEDB-06942820420450 EUDAMEDB-06942820420511 EUDAMEDB-06942820420221 EUDAMEDB-06942820421983 EUDAMEDB-06942820420238 EUDAMEDB-16942820422390 EUDAMEDB-06942820420627 EUDAMEDB-06942820420313 EUDAMEDB-06942820420474 EUDAMEDB-06942820421181 EUDAMEDB-06942820420665 EUDAMED
- Direct Marketing DI
- 06942820421785 EUDAMED06942820422232 EUDAMED06942820421525 EUDAMED06942820421600 EUDAMED06942820421754 EUDAMED06942820421716 EUDAMED06942820421631 EUDAMED06942820421778 EUDAMED06942820421846 EUDAMED06942820421518 EUDAMED06942820421402 EUDAMED06942820421662 EUDAMED06942820421549 EUDAMED06942820421686 EUDAMED06942820421532 EUDAMED06942820421808 EUDAMED06942820421877 EUDAMED06942820422027 EUDAMED06942820421624 EUDAMED06942820422249 EUDAMED06942820422034 EUDAMED06942820421389 EUDAMED06942820421747 EUDAMED06942820421839 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMEDLithuania 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69428204SPO2VG | Class IIa | Active |
| 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 (63)
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