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Electronic Sphygmomanometers

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref /Model X2510(k) K250185Model X5

by Jiangxi Aicare Medical Technology Co., Ltd

Identity

Trade Name
Electronic Sphygmomanometers EUDAMED
Device Name
Electronic Sphygmomanometers EUDAMED
Model / Reference
X2 EUDAMED
/ EUDAMED
X5 EUDAMED

Identifiers

Primary DI / UDI-DI
06972480914204 EUDAMED
06972480913658 EUDAMED
Basic UDI-DI
B-06972480914204 EUDAMED
B-06972480913658 EUDAMED
510(k) Number
K250185 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
EMDN Code
Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class 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 EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Electronic Sphygmomanometers by Jiangxi Aicare Medical Technology Co., Ltd — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Jiangxi Aicare Medical Technology Co., Ltd
EUDAMED SRN
CN-MF-000025838
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (3)

  • EUDAMED 1ac0ac64-209b-483d-9b07-852503fa2ce3 61 fields · synced Jul 29, 2026
  • FDA 510(k) K250185 24 fields · synced May 18, 2026
  • EUDAMED bb7d4e1e-93c9-484e-b424-27e59a676e62 61 fields · synced Jul 29, 2026