ACTH Calibrators
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-005926-00Model 105-005675-00、105-005692-00、105-005926-00、105-005939-00、105-005953-00、105-005940-00、105-005954-00
EMDN W0102152208
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004L-ACTH******ES | Date13 Sep 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Adrenocorticotropic hormone(CLIA)、ACTH Calibrators、ACTH Control
- Model / Reference
- 105-005675-00、105-005692-00、105-005926-00、105-005939-00、105-005953-00、105-005940-00、105-005954-00, 105-005926-00
- Primary DI / UDI-DI
- 06944904065564
- Basic UDI-DI
- 69449040004L-ACTH******ES
- EMDN Code
- W0102152208 Standards and calibrators for individual and specific hormones /proteins
- Device Class
- Class B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 794b5af2-ec5f-4136-9dd5-f7dd6b6289ac