POConePlus-AS10
by Otsuka Electronics Co., Ltd. Japan EUDAMED
Ref 03530161Model POConePlus-AS10
EMDN W0299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number498703502AS460644BJ | Date9 Jun 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- POConePlus-AS10, 03530161
- Primary DI / UDI-DI
- 04987035301615
- Basic UDI-DI
- 498703502AS460644BJ
- EMDN Code
- W0299 IVD instruments - other
- Device Class
- Class A
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- JP-MF-000001943
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Otsuka Electronics Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 0c244685-b1f4-40c4-bf96-5c3f76789639