Identity
- Trade Name
- Reusable blood pressure cuff EUDAMEDVistarmed FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Reusable Blood Pressure Cuff EUDAMEDReusable Nylon D-ring 2hose,NIBP cuff FDA UDI
- Model / Reference
- VD-004 EUDAMEDVD-022 FDA UDI
- Description
- Reusable Nylon D-ring 2hose,NIBP cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 96973521871084 EUDAMEDFDA UDI
- Basic UDI-DI
- 697352187RBPCPK EUDAMED
- 510(k) Number
- K152468 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
Reusable blood pressure cuff by Vistar Medical Supplies 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 | 697352187RBPCPK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vistar Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000011207
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 1fb1f34a-6194-41a9-97ee-169d108e52eb 61 fields · synced May 30, 2026
- FDA UDI 2d7597b8-b973-487f-a989-5b65ec0cb46a 34 fields · synced May 30, 2026