Identity
- Trade Name
- VitreJect-NE Safety Needle EUDAMED
- Device Name
- Safety needle EUDAMED
- Model / Reference
- type 3 EUDAMEDPN0650-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850040387780 EUDAMED
- Basic UDI-DI
- B-00850040387780 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hypodermic needle, single-use
VitreJect-NE Safety Needle by Zhejiang Kindly Medical Devices Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850040387780 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007594
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cf7ec471-6d52-4172-a7e2-88501dcf2c78 61 fields · synced Oct 6, 2026