Dry Fluorescence Immunoassay Analyzer
by Suzhou Helmen Precision Insturments Co., Ltd EUDAMED
Active
Ref FIC-S100, FIC-H0, FIC-M6, FIC-Q100N, FIC-H1W, FIC-M6G, FIC-H0miniModel FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697360215FICNY | Date5 Sep 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT, FIC-S100, FIC-H0, FIC-M6, FIC-Q100N, FIC-H1W, FIC-M6G, FIC-H0mini
- Primary DI / UDI-DI
- 06973602150111, 06973602150623, 06973602150319, 06973602150210, 06973602150012, 06973602150326, 06973602150616
- Basic UDI-DI
- 697360215FICNY
- Direct Marketing DI
- 06973602150111069736021506230697360215031906973602150210069736021500120697360215032606973602150616
- EMDN Code
- W0201020201, W0201069099
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000002230
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Suzhou Helmen Precision Insturments Co., Ltd
See all devices from Suzhou Helmen Precision Insturments Co., Ltd →
Properties
Show properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- New Device: No