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Hypodermic Needle with/without Safety features
EUDAMEDClass IIa (EU MDR)
Ref 91639Model Hypodermic Needle with/without Safety Features
Identity
- Trade Name
- Hypodermic Needle with/without Safety features EUDAMED
- Device Name
- Hypodermic Needle with/without Safety Features EUDAMED
- Model / Reference
- Hypodermic Needle with/without Safety Features EUDAMED91639 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095916391 EUDAMED
- Basic UDI-DI
- 890209591631H6 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hypodermic needle, single-use
Hypodermic Needle with/without Safety features by Poly Medicure Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
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- 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890209591631H6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly medicure limited
- EUDAMED SRN
- IN-MF-000043010
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED ba02da6b-8e85-47f3-ba19-045c7e8706be 61 fields · synced Jun 18, 2026