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Pulse Oximeter
EUDAMEDClass 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 925 646Ref 925 645
Identity
- Trade Name
- PULSE OXIMETER EUDAMEDVeroval Pulse oximeter EUDAMED
- 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 EUDAMED925 646 EUDAMED925 645 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040114525 EUDAMED06972040116703 EUDAMED06972040116697 EUDAMED
- Basic UDI-DI
- 697204011AOJ70X18B EUDAMED
- Direct Marketing DI
- 06972040114525 EUDAMED06972040116703 EUDAMED06972040116697 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDAustria 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 Shenzhen AOJ Medical 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 | 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 38e1f212-0f5d-4f0e-b87b-f70b90d7dbf0 61 fields · synced Oct 6, 2026
- EUDAMED 9b1cdfd0-36bf-4d7a-a819-30f2fd5fd771 61 fields · synced May 18, 2026
- EUDAMED 4cab8863-c6bf-4a35-a886-af7a5de1a3d0 61 fields · synced May 19, 2026