Identity
- Trade Name
- bluejay FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Aneroid Sphygmomanometer EUDAMED
- Model / Reference
- KS-1222 EUDAMEDN/A EUDAMEDBJ120200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975185470051 EUDAMEDFDA UDI
- Basic UDI-DI
- 6975185470001CQ 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
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6975185470001CQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wenzhou Kangshun Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000019221
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 83ad864a-f4b6-4985-9022-05922027e291 61 fields · synced Jun 18, 2026
- FDA UDI 4b9eea96-880b-49a9-845c-3acee2b3f4c3 33 fields · synced May 30, 2026