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Micro-Fine Insulin Syringes
EUDAMEDClass IIa (EU MDR)
Ref 320929Model Insulin Syringe - PolybaggedRef 324826Ref 320829Ref 324881Ref 320843Ref 320841Ref 324905Ref 320801Ref 320909Ref 320921Ref 324904Ref 324824Ref 324883Ref 324924
Identity
- Trade Name
- Micro-Fine Insulin Syringes EUDAMED
- Device Name
- Micro-Fine; Ultra-Fine EUDAMED
- Model / Reference
- Insulin Syringe - Polybagged EUDAMED320929 EUDAMED324826 EUDAMED320829 EUDAMED324881 EUDAMED320843 EUDAMED320841 EUDAMED324905 EUDAMED320801 EUDAMED320909 EUDAMED320921 EUDAMED324904 EUDAMED324824 EUDAMED324883 EUDAMED324924 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017092917 EUDAMED00383017482619 EUDAMED00383017082918 EUDAMED10383017488113 EUDAMED00383017084318 EUDAMED00383017084110 EUDAMED00383017490515 EUDAMED00383017080112 EUDAMED00383017090913 EUDAMED00383017092115 EUDAMED00383017490416 EUDAMED00383017482411 EUDAMED10383017488311 EUDAMED00383017492410 EUDAMED
- Basic UDI-DI
- 0383017INSLSYRNPBJR6K EUDAMED
- Unit of Use DI
- 80383017092982 EUDAMED80383017482684 EUDAMED80383017082983 EUDAMED80383017488181 EUDAMED80383017084383 EUDAMED80383017084185 EUDAMED80383017490580 EUDAMED80383017080187 EUDAMED80383017090988 EUDAMED80383017092180 EUDAMED80383017490481 EUDAMED80383017482486 EUDAMED80383017488389 EUDAMED80383017492485 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 (14)
- EUDAMED c7f5f1b5-2b58-4e61-b0cd-c93c0d5c19b2 61 fields · synced Aug 5, 2026
- EUDAMED 5c54217f-ca84-49ab-bf42-504020172a85 61 fields · synced May 16, 2026
- EUDAMED d5a32538-90ad-4f9b-8768-3efb68aefd7d 61 fields · synced May 16, 2026
- EUDAMED 5a737545-0840-4ea8-929e-e975daab5da5 61 fields · synced May 17, 2026
- EUDAMED 005ca37d-67e0-413e-9d1b-ff519bda3a9a 61 fields · synced May 17, 2026
- EUDAMED 1cceba81-67de-40bd-b4b6-ea08f7474ca5 61 fields · synced May 17, 2026
- EUDAMED 56a371f0-805a-4b62-9e85-ff4122ab9501 61 fields · synced May 17, 2026
- EUDAMED 5a7af2a9-1a48-4f1b-90ab-1de073ae827e 61 fields · synced May 18, 2026
- EUDAMED 734b5541-84c0-445c-a423-97d96b44c978 61 fields · synced May 18, 2026
- EUDAMED efc67b2e-58c1-4fff-9dde-9edc06808347 61 fields · synced May 18, 2026
- EUDAMED 03d8219d-86cb-4252-9c5c-280791625362 61 fields · synced May 18, 2026
- EUDAMED 0b6c7c39-715c-4bf7-8ad4-fd9fe6aa8541 61 fields · synced May 18, 2026
- EUDAMED 66fcd1ab-7195-4184-b0af-c03f471f56d0 61 fields · synced May 18, 2026
- EUDAMED 3bfccad7-10a8-4ba9-99b8-9565519022f6 61 fields · synced May 19, 2026