Identity
- Trade Name
- OcuSafe Needle EUDAMED
- Device Name
- Safety Needles EUDAMED
- Model / Reference
- type 3 EUDAMEDPN0405-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00855265008663 EUDAMED
- Basic UDI-DI
- B-00855265008663 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hypodermic needle, single-use
OcuSafe Needle by Zhejiang Kindly Medical Devices Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
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-00855265008663 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 7040f969-df63-4bda-bcfa-a671dde79ff4 61 fields · synced Oct 6, 2026