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Sterile Insulin pen needles for Single Use
EUDAMEDClass IIa (EU MDR)
Ref I23108Ref I23206Ref I23208Ref I23204Ref I43204Ref I23304Ref I23105Ref I23404Ref I23008Ref I23104Ref I43105Ref I23106Ref 361310-31-5Ref 361310-32-4Ref 6611172Ref 23204Ref 3664666010598Ref 6611171Ref 3664666010604
Identity
- Trade Name
- Sterile Insulin pen needles for Single Use EUDAMED
- Device Name
- Sterile Insulin pen needles for Single Use EUDAMED
- Model / Reference
- I23108 EUDAMEDI23206 EUDAMEDI23208 EUDAMEDI23204 EUDAMEDI43204 EUDAMEDI23304 EUDAMEDI23105 EUDAMEDI23404 EUDAMEDI23008 EUDAMEDI23104 EUDAMEDI43105 EUDAMEDI23106 EUDAMED361310-31-5 EUDAMED361310-32-4 EUDAMED6611172 EUDAMED23204 EUDAMED3664666010598 EUDAMED6611171 EUDAMED3664666010604 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949236204834 EUDAMED06949236212457 EUDAMED06949236203141 EUDAMED06949236214543 EUDAMED06949236203127 EUDAMED06949236203110 EUDAMED06949236212587 EUDAMED06949236204759 EUDAMED06949236204742 EUDAMED06949236213331 EUDAMED06949236213317 EUDAMED06949236213300 EUDAMED06949236204896 EUDAMED06949236212440 EUDAMED06949236212402 EUDAMED06949236212570 EUDAMED06949236212426 EUDAMED06949236212419 EUDAMED06949236204810 EUDAMED06949236212389 EUDAMED06949236215168 EUDAMED06949236213324 EUDAMED06949236212433 EUDAMED06949236220483 EUDAMED06949236220490 EUDAMED06949236213904 EUDAMED06949236216059 EUDAMED06949236215199 EUDAMED06949236213003 EUDAMED06949236216240 EUDAMED06949236215182 EUDAMED06949236216233 EUDAMED
- Basic UDI-DI
- 69492362N001QE EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDFrance EUDAMEDGermany EUDAMEDNetherlands 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
Sterile Insulin pen needles for Single Use by Berpu Medical Technology 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 | 69492362N001QE | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Berpu Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000012430
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (33)
- EUDAMED 1da2a713-60a5-4ae0-b19b-e3570b827e9b 61 fields · synced Oct 1, 2026
- EUDAMED 89ad6301-30f6-4f00-94d3-ed26c0063c24 61 fields · synced May 16, 2026
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- EUDAMED 33c6659f-4c5e-45ae-878e-aaee96c836a7 61 fields · synced Sep 17, 2026