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Arm Blood Pressure Monitor
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BU 518Model 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 520Ref AOJ-30FRef ARM-3011Ref ARM-30G2Ref ARM-30E+Ref AOJ-30ERef ARM-3010Ref ARM-30YRef AOJ-30DRef ARM-3012Ref ARM-30KRef ARM-3110Ref ARM-30QRef SBM 15Ref ARM-90BRef ARM-33ERef ARM-3060Ref ARM-3022Ref ARM-30WRef XS ProRef AOJ-30GRef AOJ-33B510(k) K222994Ref ARM-3030Ref AOJ-30BRef ARM-33CRef ARM-3023Ref ARM-30A+Ref ARM-30E+Ref ARM-33GRef AOJ-33A
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 EUDAMEDBU 518 EUDAMEDAOJ-30F EUDAMEDARM-3011 EUDAMEDARM-30G2 EUDAMEDARM-30E+ EUDAMEDAOJ-30E EUDAMEDARM-3010 EUDAMEDARM-30Y EUDAMEDAOJ-30D EUDAMEDARM-3012 EUDAMEDARM-30K EUDAMEDARM-3110 EUDAMEDARM-30Q EUDAMEDSBM 15 EUDAMEDARM-90B EUDAMEDARM-33E EUDAMEDARM-3060 EUDAMEDARM-3022 EUDAMEDARM-30W EUDAMEDXS Pro EUDAMEDAOJ-30G EUDAMEDAOJ-33B EUDAMEDARM-3030 EUDAMEDAOJ-30B EUDAMEDARM-33C EUDAMEDARM-3023 EUDAMEDARM-30A+ EUDAMEDARM-33G EUDAMEDAOJ-33A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972040113672 EUDAMED06972040110749 EUDAMED06972040113757 EUDAMED06972040111999 EUDAMED06972040116468 EUDAMED06972040110756 EUDAMED06972040113740 EUDAMED06972040112194 EUDAMED06972040115386 EUDAMED06972040110701 EUDAMED06972040113641 EUDAMED06972040113764 EUDAMED06972040112002 EUDAMED06972040113658 EUDAMED06972040111401 EUDAMED06972040113863 EUDAMED06972040112019 EUDAMED06972040111920 EUDAMED06972040113634 EUDAMED06972040113726 EUDAMED06972040112248 EUDAMED06972040113696 EUDAMED06972040111265 EUDAMED06972040111142 EUDAMED06972040115140 EUDAMED06972040113627 EUDAMED06972040115096 EUDAMED06972040111487 EUDAMED06972040111852 EUDAMED06972040113733 EUDAMED06972040116956 EUDAMED06972040116437 EUDAMED06972040114143 EUDAMED06972040116789 EUDAMED06972040111944 EUDAMED06972040111135 EUDAMED06972040114549 EUDAMED
- Basic UDI-DI
- 697204011AOJ30X17F EUDAMED
- Direct Marketing DI
- 06972040113672 EUDAMED06972040110749 EUDAMED06972040113757 EUDAMED06972040111999 EUDAMED06972040116468 EUDAMED06972040110756 EUDAMED06972040113740 EUDAMED06972040112194 EUDAMED06972040115386 EUDAMED06972040110701 EUDAMED06972040113641 EUDAMED06972040113764 EUDAMED06972040112002 EUDAMED06972040113658 EUDAMED06972040111401 EUDAMED06972040113863 EUDAMED06972040112019 EUDAMED06972040111920 EUDAMED06972040113634 EUDAMED06972040113726 EUDAMED06972040112248 EUDAMED06972040113696 EUDAMED06972040111265 EUDAMED06972040111142 EUDAMED06972040115140 EUDAMED06972040113627 EUDAMED06972040115096 EUDAMED06972040111487 EUDAMED06972040111852 EUDAMED06972040113733 EUDAMED06972040116956 EUDAMED06972040116437 EUDAMED06972040114143 EUDAMED06972040116789 EUDAMED06972040111944 EUDAMED06972040111135 EUDAMED06972040114549 EUDAMED
- 510(k) Number
- K222994 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Market of Registration
- Germany EUDAMEDFrance EUDAMEDSweden EUDAMEDCzechia EUDAMEDItaly EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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 Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222994 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697204011AOJ30X17F | 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 (39)
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- EUDAMED e9117a1a-2438-4288-bc31-5fdf988c3d66 61 fields · synced May 18, 2026
- FDA 510(k) K222994 24 fields · synced May 18, 2026
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- EUDAMED 9c5c266a-ec24-4cc1-974e-e510d3393303 61 fields · synced Oct 7, 2026