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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-70H
Identity
- Trade Name
- 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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040113450 EUDAMED
- Basic UDI-DI
- 697204011AOJ70X18B EUDAMED
- Direct Marketing DI
- 06972040113450 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697204011AOJ70X18B | Class IIa | Unknown |
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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 (1)
- EUDAMED 82f18b03-8689-4de4-90e4-96c8c797a1ad 61 fields · synced Jun 17, 2026