Human Chorionic Gonadotropin Controls
by Accucise Diagnostics Inc. EUDAMED
Active
Ref 1030191000Model HCG Control 1: 1 × 2 mL, HCG Control 2: 1 × 2 mL
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975090500317 | Date20 Jan 2025 | 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- Withdrawn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
- Human Chorionic Gonadotropin Controls
- Model / Reference
- HCG Control 1: 1 × 2 mL, HCG Control 2: 1 × 2 mL, 1030191000
- Primary DI / UDI-DI
- 06975090500317
- Basic UDI-DI
- B-06975090500317
- EMDN Code
- W0102152002 Hormone controls
- Device Class
- Class IVD General
- 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 (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No