Access MeMed BV Calibrator (Kit)
Ref D05592
Active
CE IVDR
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/IVDR | Number150995901AccMeMedBVCalLB 15099590787110 | Date31 Mar 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- D05592
- Primary DI / UDI-DI
- 15099590787110
- Basic UDI-DI
- 150995901AccMeMedBVCalLB
- EMDN Code
- W0102152299 Standards and calibrators - immunochemistry - other
- Device Class
- Class B
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000010288
- Authorised representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Other devices from Beckman Coulter, Inc.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No