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Pulse Oximeter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MD300CI216RModel MD300CI216R, MD300CI218R, MD300CN330R, MD300CN350R, MD300CN356R, MD300W628R
Identity
- Trade Name
- Pulse Oximeter EUDAMEDChoicemmed FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMEDChoicemmed Pulse Oximeter MD300CI216R FDA UDI
- Model / Reference
- MD300CI216R, MD300CI218R, MD300CN330R, MD300CN350R, MD300CN356R, MD300W628R EUDAMEDMD300CI216R EUDAMEDFDA UDI
- Description
- Choicemmed Pulse Oximeter MD300CI216R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942820421396 EUDAMED06942820462375 FDA UDI
- Basic UDI-DI
- 69428204SPORXE EUDAMED
- Direct Marketing DI
- 06942820421396 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pulse Oximeter by Beijing Choice Electronic Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69428204SPORXE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED b6289273-3c74-44c5-96a6-d06858314feb 61 fields · synced Jun 8, 2026
- FDA UDI ea06165d-854e-450f-8e6e-5337d4af8c47 33 fields · synced May 24, 2026