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Aneroid Sphygmomanometer
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref HS-20GRef HS-30ERef HS-201A2510(k) K092245Ref HS-60DRef HS-201C2Ref HS-50ARef HS-201Q1Ref HS-201Q2
Identity
- Trade Name
- Aneroid Sphygmomanometer EUDAMED
- Device Name
- Aneroid Sphygmomanometer EUDAMED
- Model / Reference
- HS-20G EUDAMEDHS-30E EUDAMEDHS-201A2 EUDAMEDHS-60D EUDAMEDHS-201C2 EUDAMEDHS-50A EUDAMEDHS-201Q1 EUDAMEDHS-201Q2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970384255522 EUDAMED06970384251371 EUDAMED06970384254556 EUDAMED06970384251982 EUDAMED06970384253368 EUDAMED06970384251760 EUDAMED06970384252385 EUDAMED06970384250312 EUDAMED
- Basic UDI-DI
- 697038425ASMR8 EUDAMED
- 510(k) Number
- K092245 FDA 510(k)
- FDA Product Code
- DXQ FDA 510(k)
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1120 FDA 510(k)
- Regulation Number
- 870.1120 FDA 510(k)
- Market of Registration
- Germany EUDAMEDTürkiye EUDAMEDFrance EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Aneroid Sphygmomanometer by HONSUN (NANTONG) Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K092245 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697038425ASMR8 | Class I | Active |
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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 (9)
- EUDAMED 14bb5052-cbcd-427a-afb0-be0a7a70bbf8 61 fields · synced Aug 3, 2026
- EUDAMED e3f5ff71-d73c-4757-bbe1-ae7dcc725c62 61 fields · synced May 16, 2026
- EUDAMED e773dd5b-80e5-4d3d-be3f-5006fe17a262 61 fields · synced May 18, 2026
- FDA 510(k) K092245 24 fields · synced May 18, 2026
- EUDAMED 234a8496-09dc-4d1d-8ae0-6ec04bd3a2e1 61 fields · synced Jul 9, 2026
- EUDAMED 95bb449d-0ced-4e64-952a-252a46ea4b5f 61 fields · synced Jul 9, 2026
- EUDAMED fac9471a-8483-44fd-b215-48177ccabb09 61 fields · synced Jul 11, 2026
- EUDAMED e229fe4e-5e9b-4c2a-a0cf-cffdceff1c6e 61 fields · synced Jul 16, 2026
- EUDAMED 8f803597-f969-490e-9dab-580c6283069c 61 fields · synced Aug 1, 2026