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Sicherheits-Pen-Nadel
EUDAMEDClass IIa (EU MDR)
Ref 12201005Model SD, SDWRef 12100870Model ST, STWRef 12101000Ref 12201010Ref 12100865
Identity
- Trade Name
- Sicherheits-Pen-Nadel EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- SD, SDW EUDAMED12201005 EUDAMEDST, STW EUDAMED12100870 EUDAMED12101000 EUDAMED12201010 EUDAMED12100865 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905794 EUDAMED16934047990141 EUDAMED16934047905756 EUDAMED16934047905800 EUDAMED16934047990127 EUDAMED
- Basic UDI-DI
- 69340479EU19SDMW EUDAMED69340479EU12RV 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
Yes
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
Sicherheits-Pen-Nadel 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 |
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Manufacturer
- Manufacturer
- Ningbo Medsun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011842
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 13882ee2-5bc9-4c16-8eb0-ff32d5d0f95c 61 fields · synced Jul 22, 2026
- EUDAMED dd37fb55-a8fb-446a-8c1a-810428654a03 61 fields · synced May 16, 2026
- EUDAMED 47974b19-7efd-430a-8403-dece74b1e098 61 fields · synced May 17, 2026
- EUDAMED 7d234c34-6f6e-44d4-b3cd-edef26c7b7ef 61 fields · synced May 17, 2026
- EUDAMED dd89fe71-f265-4868-b2ee-a58cf85de36a 61 fields · synced May 18, 2026