Reusable NiBP Cuff, Adult Plus (Grey), 28-40 cm
by Fysicon B.V.
Ref 01853005
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number08719689142506 | Date19 May 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number8719689142QMAPPCONSKJ 08719689142506 | Date16 May 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Reusable NiBP Cuff, Adult Plus (Grey), 28-40 cm EUDAMEDQmapp GUDID
- Generic Name
- Multiple physiological parameter monitoring support kit
- Device Name
- QMAPP Consumables
- Model / Ref / Catalog
- 01853005, Reusable NiBP Cuff, Adult Plus (Grey), 28-40 cm
- Primary DI / UDI-DI
- 08719689142506
- Basic UDI-DI
- 8719689142QMAPPCONSKJ
- 510(k) Number
- FDA Product Code
- DSA
- EMDN Code
- Z12050785 Instruments for cardiological polygraphy - consumables
- GMDN Term
- Multiple physiological parameter monitoring support kit
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.2900
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 01853005 | Reusable NiBP Cuff, Adult Plus (Grey), 28-40 cm |
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- NL-MF-000002694
Other devices from Fysicon B.V.
Properties
Other properties (22)
- 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