Prl (Clia)
by Maccura Biotechnology Co., Ltd. EUDAMED
Active
Ref IM4407203, IM4406203, IM4403203, IM4404203, IM4405203, IM4408203, IM4401203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-IM4407203JH | Date22 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Prl (Clia)
- Model / Reference
- IM4407203, IM4406203, IM4403203, IM4404203, IM4405203, IM4408203, IM4401203
- Primary DI / UDI-DI
- D-IM4407203JH, D-IM4406203JA, D-IM4403203HM, D-IM4404203HU, D-IM4405203J3, D-IM4408203JQ, D-IM4401203H7
- Basic UDI-DI
- B-IM4407203JH, B-IM4406203JA, B-IM4403203HM, B-IM4404203HU, B-IM4405203J3, B-IM4408203JQ, B-IM4401203H7
- EMDN Code
- W0102050108 Prolactin
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Maccura Biotechnology Co., Ltd.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No