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Pulse Oximeter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AOJ-70BModel AOJ-70A\AOJ-70B\AOJ-70C\AOJ-70D\AOJ-70E\OXI-70B\OXI-70D\OXI-70E\OXI-70F\OXI-70G\OXI-70HRef OXI-70ERef AOJ-70CRef AOJ-70DRef AOJ-70ARef Oxi-70D
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-70B EUDAMEDOXI-70E EUDAMEDAOJ-70C EUDAMEDFDA UDIAOJ-70D EUDAMEDAOJ-70A EUDAMEDOxi-70D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040111340 EUDAMED06972040115904 EUDAMED06972040110459 EUDAMEDFDA UDI06972040111678 EUDAMED04015588236501 EUDAMED06972040112484 EUDAMED06972040116949 EUDAMED06972040114068 EUDAMED06972040115898 EUDAMED06972040112712 EUDAMED
- Basic UDI-DI
- 697204011AOJ70X18B EUDAMED
- Direct Marketing DI
- 06972040111340 EUDAMED06972040115904 EUDAMED06972040110459 EUDAMED06972040111678 EUDAMED04015588236501 EUDAMED06972040112484 EUDAMED06972040116949 EUDAMED06972040114068 EUDAMED06972040115898 EUDAMED06972040112712 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 EUDAMEDPortugal EUDAMEDItaly 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 — 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 | 697204011AOJ70X18B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (11)
- EUDAMED d4651d58-0e40-4571-ba82-b9112dd636ee 61 fields · synced Oct 6, 2026
- EUDAMED eb9a99b1-d6f8-4020-bd2e-b4db36de3db6 61 fields · synced May 18, 2026
- EUDAMED 0a26e4b3-7b7f-4697-9cc6-d5b3d243455c 61 fields · synced May 19, 2026
- EUDAMED bd1d1720-7d3d-42ac-a8f4-329ffb930ed3 61 fields · synced May 19, 2026
- EUDAMED 3a0a3feb-b810-43e8-8f8c-f29e0ec17783 61 fields · synced May 19, 2026
- EUDAMED 4628eb34-8ec1-4fc5-82f8-90a959a632dd 61 fields · synced May 19, 2026
- EUDAMED db961c05-b27c-4402-805b-a7c80bdf7644 61 fields · synced May 19, 2026
- FDA UDI 8d20394c-2cf6-4db6-8d5b-735743315b5c 33 fields · synced May 30, 2026
- EUDAMED 436d9cd2-7465-4383-bbcc-51d4145dfe0f 61 fields · synced Jul 19, 2026
- EUDAMED a09c025a-0e8f-4fac-81ad-91e75c77690f 61 fields · synced Aug 1, 2026
- EUDAMED 12da98f6-813d-4e6d-b929-9e2426e568d9 61 fields · synced Aug 1, 2026