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Micro-Fine Insulin Syringes
EUDAMEDClass IIa (EU MDR)
Ref 320911Model Insulin Syringe - Polybagged
Identity
- Trade Name
- Micro-Fine Insulin Syringes EUDAMED
- Device Name
- Micro-Fine; Ultra-Fine EUDAMED
- Model / Reference
- Insulin Syringe - Polybagged EUDAMED320911 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017091118 EUDAMED
- Basic UDI-DI
- 0383017INSLSYRNPBJR6K EUDAMED
- Unit of Use DI
- 80383017091183 EUDAMED
- EMDN Code
- A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Micro-Fine Insulin Syringes by embecta Medical II LLC — 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 | 0383017INSLSYRNPBJR6K | Class IIa | Active |
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Manufacturer
- Manufacturer
- embecta Medical II LLC
- EUDAMED SRN
- US-MF-000044225
- Authorised Representative
- embecta Penel Limited IE-AR-000040945
Sources (1)
- EUDAMED 01297fb9-382e-4be6-900f-3b9527a25c84 61 fields · synced Jun 18, 2026