OneDose ReadyfusOR Gen2 - NRFit
by BioQ Pharma Incorporated United States EUDAMED
Ref ROPI-003, ROPI-002 EMDN A0599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number170783362 | Date23 Feb 2023 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 170783362 Withdrawn
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 23 Feb 2023
- Expires
- 24 Aug 2027
- Reason
- Other
Specification
- Trade Name
- OneDose ReadyfusOR Gen2 - NRFitOneDose ReadyfusOR Gen2
- Model / Reference
- ROPI-003, ROPI-002
- Primary DI / UDI-DI
- 00850011878187, 00850011878057
- Basic UDI-DI
- 0850011878135D
- Direct Marketing DI
- 0085001187818700850011878057
- EMDN Code
- A0599 Mechanical infusion systems, single-use - other
- Device Class
- Class IIb
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000009877
- Authorised representative
- BioQ Pharma B.V. NL-AR-000009525
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 5ebaed02-60d0-4b1b-a086-abfcccd683fd
- EUDAMED 00850011878057|0850011878135D