← Back to catalogue
Penkanülen
EUDAMEDClass IIa (EU MDR)
Ref PZN 19392959Model SD, SDWRef PZN 19392965
Identity
- Trade Name
- Penkanülen EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- SD, SDW EUDAMEDPZN 19392959 EUDAMEDPZN 19392965 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047901987 EUDAMED16934047901994 EUDAMED
- Basic UDI-DI
- 69340479EU19SDMW EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Penkanülen by Ningbo Medsun Medical 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 | 69340479EU19SDMW | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Medsun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011842
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 6b21e734-3dd5-42a7-b5d1-5a76c20df795 61 fields · synced Jul 14, 2026
- EUDAMED bf8b8333-5eeb-4470-b329-6a15ea64739c 61 fields · synced May 19, 2026