← Back to catalogue
xinle
EUDAMEDClass IIa (EU MDR)
Ref XLPII20DModel XLPII-20GRef XLPI22CModel XLPI-22GModel XLPI
Identity
- Trade Name
- xinle EUDAMEDVenous Blood Collection Needles EUDAMED
- Device Name
- Venous Blood Collection Needles EUDAMED
- Model / Reference
- XLPII-20G EUDAMEDXLPII20D EUDAMEDXLPI-22G EUDAMEDXLPI22C EUDAMEDXLPI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383616036 EUDAMED06950383616418 EUDAMED
- Basic UDI-DI
- B-06950383616036 EUDAMEDB-06950383616418 EUDAMED69503836XL0101PIPZ EUDAMED
- Unit of Use DI
- 86950383616414 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-06950383616036 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06950383616036 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 (3)
- EUDAMED 13f0d6f3-cd1e-4593-a5c0-7a050181ae85 61 fields · synced Sep 17, 2026
- EUDAMED ef997bec-5eb4-4400-8e7a-e3136ef77991 61 fields · synced May 18, 2026
- EUDAMED d1124201-3eef-4ea2-9d1a-9845237fabb4 61 fields · synced May 19, 2026