Reusable NIBP Cuff
by Unimed Medical Supplies, Inc 120 variants
Ref U1880HDModel U1883S
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69456648RNC1ZU 06945664869300 | Date28 Nov 2022 | StatusActive |
| United States | GUDID listing GUDID | Number06945664869300 | Date23 Aug 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Reusable NIBP Cuff EUDAMEDUnimed GUDID
- Generic Name
- Blood pressure cuff, reusable
- Model / Reference
- U1883S, U1880HD
- Primary DI / UDI-DI
- 06945664869300
- Basic UDI-DI
- 69456648RNC1ZU
- FDA Product Code
- DXQ
- EMDN Code
- Z1203020599 Non-invasive blood pressure gauges - other
- GMDN Term
- Blood pressure cuff, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.1120
- EU market of registration
- Poland
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000001480
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Unimed Medical Supplies, Inc.
Properties
Other properties (23)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No