Dura-Cuf, Large Adult, Dinaclick, 31 - 40 Cm, 80369-5, Single
by GE Medical Systems Information Technologies, Inc.
Ref 5822979
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8406821BUG00036GZ 00840682147583 | Date3 Feb 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- DURA-CUF Non-Invasive Blood Pressure Cuff
- Model / Reference
- 5822979
- Primary DI / UDI-DI
- 00840682147583
- Basic UDI-DI
- 8406821BUG00036GZ
- Direct Marketing DI
- 00840682147583
- EMDN Code
- Z12040180 General medicine diagnosis and monitoring instruments - hardware accessories
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000017529
- Authorised representative
- GE Medical Systems SCS FR-AR-000000344
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Properties
Other properties (12)
- Sterile: 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
- Incorporates Medicinal Product: No