Anti-Müllerian Hormone (EECL)
by Accucise Diagnostics Inc. 3 variants
Ref 1030311000Model 50 tests/kit
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-06975090502342 06975090502342 | Date21 Jan 2025 | 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- Withdrawn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
- Anti-Müllerian Hormone (EECL)
- Model / Reference
- 50 tests/kit, 1030311000
- Primary DI / UDI-DI
- 06975090502342
- Basic UDI-DI
- B-06975090502342
- EMDN Code
- W0102050215 Anti-mullerian hormone
- Device Class
- Class IVD General
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000045017
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Accucise Diagnostics Inc.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No