Identity
- Trade Name
- Aneroid Sphygmomanometer EUDAMEDLotFancy FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Aneroid Sphygmomanometer EUDAMED
- Model / Reference
- HS-201C1 EUDAMED11C-1828-H FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970384250206 EUDAMEDFDA UDI
- Basic UDI-DI
- 697038425ASMR8 EUDAMED
- 510(k) Number
- K092245 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
- Germany 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
Yes
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 Sphygmomanometer by HONSUN (NANTONG) 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 | 697038425ASMR8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- HONSUN (NANTONG) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009428
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 82e081a6-351b-43ea-b5e3-3a41bef5ea04 61 fields · synced Jun 8, 2026
- FDA UDI ee5146ee-cbf8-449a-b0bb-6d1ebda36d47 33 fields · synced May 30, 2026