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Micro-Fine Pen Needles
EUDAMEDClass IIa (EU MDR)
Ref 321119Model Pen NeedleRef 320737Ref 321121Ref 320520Ref 320953Ref 321100Ref 320651Ref 321123Ref 320697Ref 320190Ref 320519Ref 329480Ref 320590Ref 320471Ref 320470Ref 321099Ref 321122Ref 329478Ref 320954Ref 320952Ref 321118Ref 320595Ref 320498Ref 320499Ref 320650Ref 320594Ref 321120
Identity
- Trade Name
- Micro-Fine Pen Needles EUDAMED
- Device Name
- Ultra-Fine; Nano; Micro-Fine; Ultra-Fine PRO; Micro-Fine PRO; Viva; Nano 2nd Gen; Base-Fine; embecta; EUDAMED
- Model / Reference
- Pen Needle EUDAMED321119 EUDAMED320737 EUDAMED321121 EUDAMED320520 EUDAMED320953 EUDAMED321100 EUDAMED320651 EUDAMED321123 EUDAMED320697 EUDAMED320190 EUDAMED320519 EUDAMED329480 EUDAMED320590 EUDAMED320471 EUDAMED320470 EUDAMED321099 EUDAMED321122 EUDAMED329478 EUDAMED320954 EUDAMED320952 EUDAMED321118 EUDAMED320595 EUDAMED320498 EUDAMED320499 EUDAMED320650 EUDAMED320594 EUDAMED321120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00383017111939 EUDAMED00383017073732 EUDAMED00383017112134 EUDAMED00383017052034 EUDAMED00383017095314 EUDAMED00383017110031 EUDAMED00383017065119 EUDAMED00383017112332 EUDAMED00383017069735 EUDAMED00383017019037 EUDAMED00383017051938 EUDAMED00383017948030 EUDAMED00383017059033 EUDAMED00383017047139 EUDAMED00383017047030 EUDAMED00383017109936 EUDAMED00383017112233 EUDAMED00383017947835 EUDAMED00383017095437 EUDAMED00383017095215 EUDAMED00383017111830 EUDAMED00383017059538 EUDAMED00383017049836 EUDAMED00383017049935 EUDAMED00383017065010 EUDAMED00383017059439 EUDAMED00383017112035 EUDAMED
- Basic UDI-DI
- 0383017LGPNNDLSCPVK EUDAMED383017LGPNNDLSCP EUDAMED
- Unit of Use DI
- 80383017111980 EUDAMED80383017073783 EUDAMED80383017112185 EUDAMED80383017052085 EUDAMED80383017095389 EUDAMED80383017110082 EUDAMED80383017065184 EUDAMED80383017112383 EUDAMED80383017069786 EUDAMED80383017019088 EUDAMED80383017051989 EUDAMED80383017948081 EUDAMED80383017059084 EUDAMED80383017047180 EUDAMED80383017047081 EUDAMED80383017109987 EUDAMED80383017112284 EUDAMED80383017947886 EUDAMED80383017095488 EUDAMED80383017095280 EUDAMED80383017111881 EUDAMED80383017059589 EUDAMED80383017049887 EUDAMED80383017049986 EUDAMED80383017065085 EUDAMED80383017059480 EUDAMED80383017112086 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Micro-Fine Pen Needles 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 | 0383017LGPNNDLSCPVK | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- embecta Medical II LLC
- EUDAMED SRN
- US-MF-000044225
- Authorised Representative
- embecta Penel Limited IE-AR-000040945
Sources (29)
- EUDAMED 15c84c40-1db9-410d-b23c-09c99e926df5 61 fields · synced Sep 18, 2026
- EUDAMED a7158bff-c298-4544-aefd-b2ca3d2e5953 61 fields · synced May 11, 2026
- EUDAMED 1347b7cf-3903-40be-81a6-cb457cbb81e2 61 fields · synced May 11, 2026
- EUDAMED 19bbe84d-2f5c-435a-9942-ed0ef1719035 61 fields · synced May 11, 2026
- EUDAMED 5bb073bc-2234-4db3-b49e-8fb57bd14a24 61 fields · synced May 16, 2026
- EUDAMED d8805411-2e54-4571-a1b6-a6daaff42dac 61 fields · synced May 16, 2026
- EUDAMED 4e30cc9d-7697-48bb-9b0b-fc041db5c88b 61 fields · synced May 16, 2026
- EUDAMED 661d8ff7-e4e5-41bd-b146-55a6a9aa35e6 61 fields · synced May 16, 2026
- EUDAMED c5222e4f-c30f-47e2-b6b6-8e539adcaea8 61 fields · synced May 16, 2026
- EUDAMED 467a9f03-0624-4619-8de5-736b6938839a 61 fields · synced May 17, 2026
- EUDAMED 67381bd7-4dc5-4ba5-85e4-37cbaf715bbe 61 fields · synced May 17, 2026
- EUDAMED 168b8dd3-7d4f-46ba-bc1d-12981d0fbe00 61 fields · synced May 17, 2026
- EUDAMED 95166e70-90c4-498e-80a6-b3875a30f818 61 fields · synced May 17, 2026
- EUDAMED 12b325b3-9db8-412e-8dce-c8d70ba3dd6b 61 fields · synced May 17, 2026
- EUDAMED a2c34302-20f5-41e2-8a20-59a84107c86a 61 fields · synced May 17, 2026
- EUDAMED 06ad43ea-20a2-454f-af8d-fc16eeaa956a 61 fields · synced May 17, 2026
- EUDAMED ef3fc1c1-22e0-452a-b89e-536aeea31ab5 61 fields · synced May 17, 2026
- EUDAMED 3e965421-9056-448e-82ec-daea8700f357 61 fields · synced May 17, 2026
- EUDAMED 6a282de5-38bb-4c0e-8366-a4ac9745977a 61 fields · synced May 18, 2026
- EUDAMED ed297b81-c941-418a-a382-902913e556b6 61 fields · synced May 18, 2026
- EUDAMED b9f53e90-703e-4054-9435-45ddf480b077 61 fields · synced May 18, 2026
- EUDAMED 94eadec4-60b9-48aa-86b4-224b2e0f12ce 61 fields · synced May 18, 2026
- EUDAMED 1edf7563-94ad-498b-b848-47dd87372490 61 fields · synced May 18, 2026
- EUDAMED 67bfedf6-2ee8-4f1c-a20c-78f7f4eda972 61 fields · synced May 18, 2026
- EUDAMED b45fface-7aa5-4fc0-89fc-dbda48f19d09 61 fields · synced May 18, 2026
- EUDAMED 2ebc456b-1944-4cbd-bd40-bd017e8f530e 61 fields · synced May 18, 2026
- EUDAMED 45f2c007-c8fa-4930-974d-35db011c9802 61 fields · synced May 18, 2026
- EUDAMED 068bdf69-f2ae-4d97-9af6-84b0bccf063e 61 fields · synced Jul 9, 2026
- EUDAMED 1b745f84-bc19-4b42-b883-295f44d9b13c 61 fields · synced Jul 30, 2026