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Single-use Containers for Human Venous Blood Specimen Collection
EUDAMEDClass A (EU MDR)
Ref XLSPC-E3K9Model K3EDTA
Identity
- Trade Name
- Single-use Containers for Human Venous Blood Specimen Collection EUDAMED
- Device Name
- Single-use Containers for Human Venous Blood Specimen Collection EUDAMED
- Model / Reference
- K3EDTA EUDAMEDXLSPC-E3K9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383630902 EUDAMED
- Basic UDI-DI
- 69503836XL0309E3KYK EUDAMED
- Unit of Use DI
- 86950383630908 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Single-use containers for human venous blood specimen collection are a critical component in laboratory testing and diagnosis. Designed with sterility and safety in mind, these containers feature a proprietary membrane that prevents contamination while maintaining the integrity of the blood sample.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69503836XL0309E3KYK | Class A | Active |
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Manufacturer
- Manufacturer
- Hebei Xinle Sci&Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000016692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5d320342-b328-4c68-abab-4b664a41829e 61 fields · synced Jul 14, 2026