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Arm Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ARM-30HModel ARM-30E+,AOJ-30B/A/C/D/E/F/G,ARM-30V/33C/D/E/F/G/30A+/30G1/30G2/30Q/30G+/30M/30M+/30S/30T/30J/30K/30H/30W/30C+/30U/30Y,AOJ-33A/B,ARM-HA101/HA101+,ARM-90B,XS Pro,ARM-3010/3011/3012/3013/3110/3040/3030/3060/3020/3021/3022/3023/3120,SBM 15,BU 518/BU 520510(k) K250116
Identity
- Trade Name
- Arm Blood Pressure Monitor EUDAMED
- Device Name
- Arm blood pressure monitor EUDAMED
- Model / Reference
- ARM-30E+,AOJ-30B/A/C/D/E/F/G,ARM-30V/33C/D/E/F/G/30A+/30G1/30G2/30Q/30G+/30M/30M+/30S/30T/30J/30K/30H/30W/30C+/30U/30Y,AOJ-33A/B,ARM-HA101/HA101+,ARM-90B,XS Pro,ARM-3010/3011/3012/3013/3110/3040/3030/3060/3020/3021/3022/3023/3120,SBM 15,BU 518/BU 520 EUDAMEDARM-30H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040111418 EUDAMED
- Basic UDI-DI
- 697204011AOJ30X17F EUDAMED
- Direct Marketing DI
- 06972040111418 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Arm Blood Pressure Monitor by Shenzhen AOJ Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250116 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011AOJ30X17F | 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 (2)
- EUDAMED e71cb190-83d1-4478-8bde-9807bef31051 85 fields · synced Jun 19, 2026
- FDA 510(k) K250116 1 fields · synced May 18, 2026