Identity
- Trade Name
- xinle EUDAMEDVenous Blood Collection Needles EUDAMED
- Device Name
- Venous Blood Collection Needles EUDAMED
- Model / Reference
- XLPII-18G EUDAMEDXLPII18C EUDAMEDXLPII EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383615992 EUDAMED
- Basic UDI-DI
- B-06950383615992 EUDAMED69503836XL0102PIIZS EUDAMED
- Unit of Use DI
- 86950383615998 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-06950383615992 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06950383615992 | 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 2e2e77e3-7d1b-442a-a858-03f4bf97aeae 61 fields · synced Jun 19, 2026
- EUDAMED 7de5d56a-9b94-413a-9a89-9404cbe2f9a0 61 fields · synced May 18, 2026