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Sterile Insulin pen needles for Single Use
EUDAMEDClass IIa (EU MDR)
Ref I23205
Identity
- Trade Name
- Sterile Insulin pen needles for Single Use EUDAMED
- Device Name
- Sterile Insulin pen needles for Single Use EUDAMED
- Model / Reference
- I23205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949236203134 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
- France 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 |
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Manufacturer
- Manufacturer
- Berpu Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000012430
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED bc969337-41ed-48d6-94dc-b212d4037c2a 61 fields · synced Jun 19, 2026