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Aneroid Sphygmomanometer

EUDAMEDFDA UDI

Class I (EU MDR)

Ref N/A

by Wenzhou Kangshun Medical Devices Co., Ltd

Identity

Trade Name
konsunmed FDA UDI
Generic Name
Aneroid manual sphygmomanometer FDA UDI
Device Name
Aneroid Sphygmomanometer EUDAMED
Model / Reference
N/A EUDAMED
KS-2201 FDA UDI

Identifiers

Primary DI / UDI-DI
06975185470112 EUDAMEDFDA UDI
Basic UDI-DI
6975185470002CS EUDAMED
510(k) Number
K230859 FDA UDI
FDA Product Code
DXQ FDA UDI
EMDN Code
C9006 ANEROID SPHYGMOMANOMETERS EUDAMED
GMDN Term
Aneroid manual sphygmomanometer FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.1120 FDA UDI
Market of Registration
Türkiye EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Aneroid Sphygmomanometer by Wenzhou Kangshun Medical Devices CO., LTD — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
CN-MF-000019221
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED d31645d8-d18e-4e1d-9725-b298f689743d 61 fields · synced Jun 19, 2026
  • FDA UDI 68b26e5a-1a2a-44d9-93d1-b8d80cb34744 33 fields · synced May 30, 2026