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dispoGUARD Safety injection needle
EUDAMEDClass IIa (EU MDR)
Ref INB-045X12
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- dispoGUARD Safety injection needle EUDAMED
- Device Name
- sterile hypodermic needle EUDAMED
- Model / Reference
- INB-045X12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996838301 EUDAMED
- Basic UDI-DI
- B-05907996838301 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
dispoGUARD Safety injection needle by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class IIa — MDD — listed in EUDAMED
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-05907996838301 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED e75695ae-f356-43cb-895b-82eaa4628160 61 fields · synced Oct 8, 2026