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Insulin Pen Needle
EUDAMEDClass IIa (EU MDR)
Ref IV140832Model 29G、30G、31G、32G 、33GRef IV140831Ref IV140829
Identity
- Trade Name
- Insulin Pen Needle EUDAMED
- Device Name
- Insulin Pen Needle EUDAMED
- Model / Reference
- 29G、30G、31G、32G 、33G EUDAMEDIV140832 EUDAMEDIV140831 EUDAMEDIV140829 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013964140 EUDAMED06972013964133 EUDAMED06972013964119 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSIP001P3 EUDAMED
- Direct Marketing DI
- 06972013964140 EUDAMED06972013964133 EUDAMED06972013964119 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Hypodermic needle, single-use
Insulin Pen Needle by Multigate Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hypodermic needle, single-use.
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- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
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 | 697201396MU2ASNNNSIP001P3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (6)
- EUDAMED 563edbd8-8b5c-4229-989d-6705df478216 61 fields · synced Jul 29, 2026
- EUDAMED a49e886a-eb25-4750-8f0f-b9d4e3122f1c 61 fields · synced May 18, 2026
- EUDAMED bb2d90b1-0cb5-4e28-b343-8d4fac4e807f 61 fields · synced May 18, 2026
- EUDAMED 572c6a77-ef75-4e27-b127-373e82b881e9 61 fields · synced Jul 14, 2026
- EUDAMED 09808b91-1ab2-4c01-b218-0271e7b439b9 61 fields · synced Jul 16, 2026
- EUDAMED eab700ec-8bf2-4ab2-8195-aa67ed609398 61 fields · synced Jul 29, 2026