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Ultra-Fine Insulin Syringes
EUDAMEDClass IIa (EU MDR)
Ref 326675Model Insulin Syringe - BlisterRef 326674Ref 326719Ref 328820Model Insulin Syringe - PolybaggedRef 324903Ref 324902Ref 326702Ref 328457Ref 326725Ref 324900Ref 324901
Identity
- Trade Name
- Ultra-Fine Insulin Syringes EUDAMED
- Device Name
- Ultra-Fine EUDAMEDMicro-Fine; Ultra-Fine EUDAMED
- Model / Reference
- Insulin Syringe - Blister EUDAMED326675 EUDAMED326674 EUDAMED326719 EUDAMEDInsulin Syringe - Polybagged EUDAMED328820 EUDAMED324903 EUDAMED324902 EUDAMED326702 EUDAMED328457 EUDAMED326725 EUDAMED324900 EUDAMED324901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017667511 EUDAMED00383017667412 EUDAMED00383017671914 EUDAMED00383017882013 EUDAMED00383017490317 EUDAMED00383017490218 EUDAMED00383017670214 EUDAMED00383017845735 EUDAMED00383017672515 EUDAMED00383017490010 EUDAMED00383017490119 EUDAMED
- Basic UDI-DI
- 0383017INLSYRNGJR8V EUDAMED0383017INSLSYRNPBJR6K EUDAMED
- Unit of Use DI
- 80383017667586 EUDAMED80383017667487 EUDAMED80383017671989 EUDAMED80383017882088 EUDAMED80383017490382 EUDAMED80383017490283 EUDAMED80383017670289 EUDAMED80383017845786 EUDAMED80383017672580 EUDAMED80383017490085 EUDAMED80383017490184 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
Ultra-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 | 0383017INLSYRNGJR8V | 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 (11)
- EUDAMED 4c0fc39b-b101-49b9-a78f-feca1659b714 61 fields · synced Jul 26, 2026
- EUDAMED c7cca805-3a4b-4ec8-b846-cfe57ed9eec7 61 fields · synced May 16, 2026
- EUDAMED 8f5c7b5a-10b6-4c94-a738-fe99b0cd4b7c 61 fields · synced May 16, 2026
- EUDAMED 05df1bb5-f85d-47fe-9bad-c19a74036335 61 fields · synced May 17, 2026
- EUDAMED 6f36cfed-6da4-4177-913a-6e0714345a2b 61 fields · synced May 17, 2026
- EUDAMED 868ea73b-bf58-4535-9eba-44c0947b4346 61 fields · synced May 17, 2026
- EUDAMED ffb2a30d-1bb7-433e-81ad-a2884b875bed 61 fields · synced May 17, 2026
- EUDAMED 180992ed-71d8-4ba1-be06-625714c6bafd 61 fields · synced May 17, 2026
- EUDAMED 2824e844-88d4-491c-b7b4-7118c4a5244f 61 fields · synced May 18, 2026
- EUDAMED 3da2c60a-3ba9-4c73-9e64-96c92597807b 61 fields · synced May 18, 2026
- EUDAMED 11cd90f6-544e-40c8-aaf8-e72fd9d57158 61 fields · synced May 19, 2026