human Growth Hormone (CLIA)
by Maccura Biotechnology Co., Ltd. 4 variants
Ref IM4404006, IM4405206, IM4408206, IM4401206, IM4403206
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-IM4404006HQ | Date22 May 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- human Growth Hormone (CLIA)
- Model / Reference
- IM4404006, IM4405206, IM4408206, IM4401206, IM4403206
- Primary DI / UDI-DI
- D-IM4404006HQ, D-IM4405206J9, D-IM4408206JW, D-IM4401206HD, D-IM4403206HT
- Basic UDI-DI
- B-IM4404006HQ, B-IM4405206J9, B-IM4408206JW, B-IM4401206HD, B-IM4403206HT
- EMDN Code
- W0102060402 Human growth hormone
- Device Class
- Class IVD General
- EU 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