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Insulin Pen Needles
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref PN32-4-FLModel IPN-32-4Ref PN31-5Ref PRO5-32-5-PROMORef PRO5-32-4Ref PN32-4Ref PN32-5-FL-PROMORef PN32-8Ref PN32-5Ref PN32-4-FL-PROMO
Identity
- Device Name
- Insulin Pen Needles EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDPN32-4-FL EUDAMEDPN31-5 EUDAMEDPRO5-32-5-PROMO EUDAMEDPRO5-32-4 EUDAMEDPN32-4 EUDAMEDPN32-5-FL-PROMO EUDAMEDPN32-8 EUDAMEDPN32-5 EUDAMEDPN32-4-FL-PROMO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615370002577 EUDAMED03401060081713 EUDAMED03615370006261 EUDAMED03615370005844 EUDAMED03401060081829 EUDAMED06975965292187 EUDAMED03401060081812 EUDAMED03401060081720 EUDAMED03615370004595 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED
- Unit of Use DI
- 13615370002574 EUDAMED13401060081710 EUDAMED13615370006268 EUDAMED13615370005841 EUDAMED13401060081826 EUDAMED86975965292183 EUDAMED13401060081819 EUDAMED13401060081727 EUDAMED13615370004592 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
Insulin Pen Needles by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K210059 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697122740IPNPZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (10)
- EUDAMED 84250430-2fbd-462b-86ae-32498126a463 61 fields · synced Oct 8, 2026
- EUDAMED 475107b2-d6b6-42cd-9850-ff844ef374bc 61 fields · synced May 16, 2026
- EUDAMED b3807718-262b-4190-8eef-1a7ee0ea9030 61 fields · synced May 17, 2026
- EUDAMED a8c97d3e-25ea-442a-9253-a2e04612f7e9 61 fields · synced May 17, 2026
- EUDAMED 8de296cc-0c3d-4df9-8d10-5243c2ec1a49 61 fields · synced May 17, 2026
- EUDAMED 6fd217e2-1787-4494-bce2-2ab1a98dab85 61 fields · synced May 18, 2026
- EUDAMED 5e081715-fe36-4da4-89ed-92384f48bd55 61 fields · synced May 18, 2026
- EUDAMED 1c547bf9-fa25-4973-8814-fd43642ec94b 61 fields · synced Jul 17, 2026
- EUDAMED 1877538b-1ea9-4d06-8d60-c7a8bac3daad 61 fields · synced Jul 31, 2026
- FDA 510(k) K210059 1 fields · synced May 18, 2026