Identity
- Trade Name
- Insulin Syringe EUDAMED
- Device Name
- Insulin Syringe EUDAMED
- Model / Reference
- 0.3ml、0.5ml、1ml EUDAMEDIV121131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601009186 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSIS002PS EUDAMED
- EMDN Code
- A02010602 INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Insulin Syringe by Multigate Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697201396MU2ASNNNSIS002PS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED 763e0d40-e345-43db-8122-a2e1843051c9 61 fields · synced Jun 20, 2026