Single-use Containers for Human Capillary Blood Specimen Collection
by Hebei Xinle Sci&Tech Co., Ltd EUDAMED
Active
Ref XLMA-EK20Model K2EDTA
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69503836XL0407EKR3 | Date27 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- K2EDTA, XLMA-EK20
- Primary DI / UDI-DI
- 06950383631602
- Basic UDI-DI
- 69503836XL0407EKR3
- Unit of Use DI
- 86950383631608
- EMDN Code
- W0501010203 Blood collection, capillary tubes
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000016692
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Hebei Xinle Sci&Tech Co., Ltd.
Properties
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No