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Insulin pen needle for single use 0.33mm(29G)×4mm
EUDAMEDClass IIa (EU MDR)
Ref NI29Model 0.25mm (31G), 0.30mm (30G), 0.33mm (29G)
Identity
- Trade Name
- Insulin pen needle for single use 0.33mm(29G)×4mm EUDAMED
- Device Name
- Insulin pen needle for single use EUDAMED
- Model / Reference
- 0.25mm (31G), 0.30mm (30G), 0.33mm (29G) EUDAMEDNI29 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756717006 EUDAMED
- Basic UDI-DI
- 69207567YDSBYZT0001QP EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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 needle for single use 0.33mm(29G)×4mm by Jiangxi Hongda Medical Equipment Group Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 69207567YDSBYZT0001QP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Ltd.
- EUDAMED SRN
- CN-MF-000006019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED dc6f3306-a0f6-4320-b792-5c23330a3e17 61 fields · synced Oct 9, 2026