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Pulse Oximeter
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref AOJ-70AModel AOJ-70A\AOJ-70B\AOJ-70C\AOJ-70D\AOJ-70E\OXI-70B\OXI-70D\OXI-70E\OXI-70F\OXI-70G\OXI-70H
Identity
- Trade Name
- Pulse Oximeter EUDAMEDN/A FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- AOJ-70A\AOJ-70B\AOJ-70C\AOJ-70D\AOJ-70E\OXI-70B\OXI-70D\OXI-70E\OXI-70F\OXI-70G\OXI-70H EUDAMEDAOJ-70A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972040110435 EUDAMEDFDA UDI
- Basic UDI-DI
- 697204011AOJ70X18B EUDAMED
- Direct Marketing DI
- 06972040110435 EUDAMED
- 510(k) Number
- K202173 FDA UDI
- 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
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Pulse Oximeter by Shenzhen AOJ Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202173 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232989 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011AOJ70X18B | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen AOJ Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018386
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED 71222ff9-18eb-4b00-be50-da63ab51179a 61 fields · synced Oct 6, 2026
- FDA UDI 531f51e2-9c61-4ee8-b8da-50edf3b2ee40 33 fields · synced May 30, 2026
- FDA 510(k) K202173 1 fields · synced May 18, 2026