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Sterile Safety Insulin Pen Needle for Single Use
EUDAMEDClass IIa (EU MDR)
Ref SFSAFE5
Identity
- Trade Name
- Sterile Safety Insulin Pen Needle for Single Use EUDAMED
- Device Name
- Sterile Safety Insulin Pen Needle for Single Use EUDAMED
- Model / Reference
- SFSAFE5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949236217438 EUDAMED
- Basic UDI-DI
- 69492362N004QL EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH 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 Safety Insulin Pen Needle 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 | 69492362N004QL | 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 53f8e59f-f367-4c23-865a-d5818b6714c2 61 fields · synced Jun 19, 2026