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dispoGUARD Safety injection needle
EUDAMEDClass IIa (EU MDR)
Ref INB-12X40
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- dispoGUARD Safety injection needle EUDAMED
- Device Name
- sterile hypodermic needle EUDAMED
- Model / Reference
- INB-12X40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996838271 EUDAMED
- Basic UDI-DI
- B-05907996838271 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-05907996838271 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED 1c6be595-e4b9-4a91-b48d-546660f9d9d4 61 fields · synced Oct 10, 2026