Identity
- Trade Name
- xinle EUDAMEDVenous Blood Collection Needles EUDAMED
- Device Name
- Venous Blood Collection Needles EUDAMED
- Model / Reference
- XLPI-22G EUDAMEDXLPI22B EUDAMEDXLPI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383615954 EUDAMED
- Basic UDI-DI
- B-06950383615954 EUDAMED69503836XL0101PIPZ EUDAMED
- Unit of Use DI
- 86950383615950 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
xinle by Hebei Xinle Sci&Tech Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06950383615954 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06950383615954 | 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 b00d2fbb-2b1b-4c0f-bef3-7b5c20d8cb6e 61 fields · synced Jul 10, 2026
- EUDAMED 77b1ac0f-cac1-4b6f-81b8-1dc8e3cd5fc0 61 fields · synced May 16, 2026