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Aneroid Sphygmomanometers

EUDAMEDFDA UDI

Class I (EU MDR)

Ref KS-1222Ref N/A

by Wenzhou Kangshun Medical Devices Co., Ltd

Identity

Trade Name
ANEROID SPHYGMOMANOMETERS EUDAMED
konsunmed FDA UDI
Generic Name
Aneroid manual sphygmomanometer FDA UDI
Device Name
Aneroid Sphygmomanometer EUDAMED
Aneroid Sphygmomanometer EUDAMED
Model / Reference
KS-1222 EUDAMEDFDA UDI
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
06975185470273 EUDAMED
06975185470075 EUDAMEDFDA UDI
Basic UDI-DI
6975185470001CQ EUDAMED
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
Hungary EUDAMED
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

No

FDA UDI

Aneroid Sphygmomanometers 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 (3)

  • EUDAMED b010f58e-7078-4db8-8cec-f480b425dbb2 61 fields · synced Oct 6, 2026
  • EUDAMED d3a268ec-5896-4912-9693-01348bb20028 61 fields · synced May 18, 2026
  • FDA UDI 2c43e7f8-741c-4d55-8807-0a81c264818a 33 fields · synced May 30, 2026