Newborn Blood Collection Card
by Shandong Chengwu Ronghua Biotechnology Co., Ltd. EUDAMED
Active
Ref 100 sheets/box (3 collection circles)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number698036138HX90K5 | Date10 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Newborn Blood Collection Card
- Model / Reference
- 100 sheets/box (3 collection circles)
- Primary DI / UDI-DI
- 06980361389034
- Basic UDI-DI
- 698036138HX90K5
- EMDN Code
- W0501010280,W0501010299
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000057166
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No