Pylon Diluent 55
by ET Healthcare (Suzhou) Co., Ltd. China EUDAMED
Ref 22-0054Model 2 bottles (30 mL/bottle)/kit,10 bottles (30 mL/bottle)/ kit
EMDN W0102010114
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697648502D55RH | Date13 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 2 bottles (30 mL/bottle)/kit, 10 bottles (30 mL/bottle)/ kit, 22-0054
- Primary DI / UDI-DI
- 06976485022551
- Basic UDI-DI
- 697648502D55RH
- Direct Marketing DI
- 06976485022551
- EMDN Code
- W0102010114 Buffers (unassignable), supplem. reagents, etc (ig's)
- Device Class
- Class A
Manufacturer details
- EUDAMED SRN
- CN-MF-000039448
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from ET Healthcare (Suzhou) 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
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 3e8ef432-ab50-4d87-978d-13f29abf5366