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INSUNEED Insulin pen needles
EUDAMEDClass IIa (EU MDR)
Ref 23106Model Normal typeRef 23105Ref 22912Ref 23108Ref 23010Ref 23304Ref 23204
Identity
- Trade Name
- INSUNEED Insulin pen needles EUDAMEDINSUNEED Insulin pen needles EUDAMED
- Device Name
- Insulin Pen Needle EUDAMED
- Model / Reference
- Normal type EUDAMED23106 EUDAMED23105 EUDAMED22912 EUDAMED23108 EUDAMED23010 EUDAMED23304 EUDAMED23204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923033454265 EUDAMED06923033454234 EUDAMED06923033455019 EUDAMED06923033454296 EUDAMED06923033455026 EUDAMED06923033454210 EUDAMED06923033455118 EUDAMED06923033455095 EUDAMED
- Basic UDI-DI
- 69230334202002a01901MY EUDAMED
- Direct Marketing DI
- 06923033454265 EUDAMED06923033454234 EUDAMED06923033455019 EUDAMED06923033454296 EUDAMED06923033455026 EUDAMED06923033454210 EUDAMED06923033455118 EUDAMED06923033455095 EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMEDA0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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
INSUNEED Insulin pen needles by Zhejiang Kindly Medical Devices 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 | 69230334202002a01901MY | 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 (8)
- EUDAMED 1176bc61-213b-440c-a992-146698aded46 61 fields · synced Oct 7, 2026
- EUDAMED 2816bae5-b933-4010-b6a4-537cbbe04a4d 61 fields · synced May 16, 2026
- EUDAMED ab963fcc-40b0-431c-a58c-a2ba21db7011 61 fields · synced May 17, 2026
- EUDAMED 02d8bbb6-0998-422f-b280-d2f26026134d 61 fields · synced May 17, 2026
- EUDAMED 9a0a4c22-3f63-453c-a515-63e48224c018 61 fields · synced May 17, 2026
- EUDAMED 96bead51-d4ce-4f2e-b1e2-082f06ccc9c6 61 fields · synced May 18, 2026
- EUDAMED 50970d83-d08b-459e-bb91-01676063f972 61 fields · synced Jun 18, 2026
- EUDAMED a12a5d39-fa89-468a-834c-498d6a7b5402 61 fields · synced Oct 6, 2026