Identity
- Trade Name
- DISPOJEKT EUDAMED
- Device Name
- Hypodermic Needles EUDAMED
- Model / Reference
- 04964 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18903347049642 EUDAMED
- Basic UDI-DI
- 8903347A010101YK EUDAMED
- Direct Marketing DI
- 18903347049642 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta 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
Dispojekt by Hindustan Syringes & Medical Devices Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8903347A010101YK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hindustan Syringes & Medical Devices Ltd.
- EUDAMED SRN
- IN-MF-000019164
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 1d350379-d7b8-4aa8-a8bc-645b30c7647f 61 fields · synced Jul 22, 2026