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Venous Blood Collection Needles
EUDAMEDClass IIa (EU MDR)
Ref XLPII21BModel XLPIIModel XLPII-21G
Identity
- Trade Name
- Venous Blood Collection Needles EUDAMEDxinle EUDAMED
- Device Name
- Venous Blood Collection Needles EUDAMED
- Model / Reference
- XLPII EUDAMEDXLPII21B EUDAMEDXLPII-21G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383616043 EUDAMED
- Basic UDI-DI
- 69503836XL0102PIIZS EUDAMEDB-06950383616043 EUDAMED
- Unit of Use DI
- 86950383616049 EUDAMED
- EMDN Code
- A01010502 NEEDLES FOR COLLECTION UNDER VACUUM, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Venous Blood Collection Needles by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69503836XL0102PIIZS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69503836XL0102PIIZS | Class IIa | 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 (2)
- EUDAMED 5a14dbbd-4940-407d-b71d-c3f04f2b5024 61 fields · synced Jul 14, 2026
- EUDAMED 5e58f027-716c-40fa-b583-9807f5d7ebfb 61 fields · synced May 18, 2026