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Safety insulin pen needle
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SFINE-531Model safety typeRef SPN3304SRef SPN3204SRef 029ARef SFINE-630Ref SPN3008SRef SFINE-830Ref SPN3005SRef SPN3105S
Identity
- Trade Name
- Safety insulin pen needle EUDAMED
- Device Name
- Safety Insulin Pen Needle EUDAMED
- Model / Reference
- safety type EUDAMEDSFINE-531 EUDAMEDSPN3304S EUDAMEDSPN3204S EUDAMED029A EUDAMEDSFINE-630 EUDAMEDSPN3008S EUDAMEDSFINE-830 EUDAMEDSPN3005S EUDAMEDSPN3105S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923033453671 EUDAMED06923033454494 EUDAMED06923033454531 EUDAMED06923033454807 EUDAMED06923033454579 EUDAMED06923033453749 EUDAMED06923033454517 EUDAMED06923033453695 EUDAMED06923033454500 EUDAMED06923033454524 EUDAMED
- Basic UDI-DI
- 69230334202002a01902N2 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMEDA0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMEDSweden 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Safety insulin pen needle by Zhejiang Kindly Medical Devices Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K213183 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69230334202002a01902N2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007594
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (11)
- EUDAMED c1af3223-8562-48b4-bf25-3cf18d36882b 61 fields · synced Oct 6, 2026
- EUDAMED 89938633-fd62-4441-bfe9-9d9b7cd0a1ac 61 fields · synced May 16, 2026
- EUDAMED 4136c239-0e08-4f7b-9b0b-2bbac71dddb2 61 fields · synced May 17, 2026
- EUDAMED 50b3fb6b-6688-4cb4-bbba-f5578ff45b8b 61 fields · synced May 17, 2026
- EUDAMED 90f97381-3b38-4b78-be63-9065163c1761 61 fields · synced May 17, 2026
- EUDAMED a70a1341-abd6-4372-b6ff-3bfc37403695 61 fields · synced May 18, 2026
- EUDAMED 28cffe2b-5ef9-4cbc-b235-3d03001c9ea6 61 fields · synced May 18, 2026
- EUDAMED 4dd3a80a-169d-45cf-9835-07ff6d178e0b 61 fields · synced May 18, 2026
- EUDAMED a6308186-557d-41c7-992b-1349a1351b2c 61 fields · synced May 18, 2026
- EUDAMED 7e2f0076-4740-4b94-80aa-fc55f36334ed 61 fields · synced May 18, 2026
- FDA 510(k) K213183 1 fields · synced May 18, 2026