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dispoFINE Injection needle
EUDAMEDClass IIa (EU MDR)
Ref IN-16X40
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- dispoFINE Injection needle EUDAMED
- Device Name
- sterile hypodermic needle EUDAMED
- Model / Reference
- IN-16X40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996836314 EUDAMED
- Basic UDI-DI
- B-05907996836314 EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O 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
dispoFINE Injection needle by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05907996836314 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED 3edfa0de-d8f5-47c4-9c1e-a750ebe10000 61 fields · synced Oct 8, 2026