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Aneroid Sphygmomanometer
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref N/A510(k) K230859Model KS-1222
Identity
- Trade Name
- Lightning FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Aneroid Sphygmomanometer EUDAMEDAneroid Sphygmomanometer EUDAMED
- Model / Reference
- N/A EUDAMEDKS-1222 EUDAMED01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975185470167 EUDAMEDFDA UDI26975185471014 EUDAMED
- Basic UDI-DI
- 6975185470002CS EUDAMED6975185470001CQ 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Poland EUDAMEDGreece 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aneroid Sphygmomanometer by Wenzhou Kangshun Medical Devices CO., LTD — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K230859 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6975185470002CS | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Kangshun Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000019221
- FDA Applicant
- Wenzhou Kangshun Medical Devices Co.,Ltd
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 5645fbb6-5c19-47d5-9f30-59f16168de28 85 fields · synced Oct 6, 2026
- EUDAMED ecb3e7cf-2fc2-4701-8f1f-72f36f757d07 61 fields · synced May 17, 2026
- FDA UDI a69ee789-8299-40bc-9b56-09ae23633cd2 33 fields · synced May 30, 2026
- FDA 510(k) K230859 1 fields · synced May 18, 2026