← Back to catalogue
Sterile Safety Insulin Pen Needle for Single Use
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref I33005Ref I33008Ref SFSAFE8
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
- I33005 EUDAMEDI33008 EUDAMEDSFSAFE8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949236212914 EUDAMED06949236212921 EUDAMED06949236204735 EUDAMED06949236213638 EUDAMED06949236204728 EUDAMED06949236212747 EUDAMED06949236217445 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
- Germany EUDAMEDItaly EUDAMEDSpain EUDAMEDFrance 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212514 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181447 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69492362N004QL | 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 (8)
- EUDAMED 0f0a2848-6113-4204-bc44-88f90619cd66 61 fields · synced Aug 2, 2026
- EUDAMED 1b3c7fa6-4d04-490e-b3b3-75173a32e6e7 61 fields · synced May 17, 2026
- EUDAMED a852a199-6478-41db-87dd-c371ffdbabd3 61 fields · synced May 17, 2026
- EUDAMED cd111b97-72ba-4a10-b9bf-b656863463d9 61 fields · synced May 19, 2026
- EUDAMED e434fcbc-e72b-41a1-8124-038d2b2e7ed5 61 fields · synced May 19, 2026
- EUDAMED d8b84041-21f4-4993-b44c-9559c56f6bf9 61 fields · synced May 19, 2026
- EUDAMED b9458625-a919-44fb-b63d-a1cd4517a90c 61 fields · synced Jul 14, 2026
- FDA 510(k) K212514 1 fields · synced May 18, 2026