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DIAVUE Prudential Sicherheits Pen-Nadel
EUDAMEDClass IIa (EU MDR)
Ref 8436Model type 820Ref 8435
Identity
- Trade Name
- DIAVUE Prudential Sicherheits Pen-Nadel EUDAMED
- Device Name
- Safety pen needle EUDAMED
- Model / Reference
- type 820 EUDAMED8436 EUDAMED8435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996095186 EUDAMED05907996095179 EUDAMED
- Basic UDI-DI
- B-05907996095186 EUDAMEDB-05907996095179 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DIAVUE Prudential Sicherheits Pen-Nadel by Htl Strefa S A — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05907996095186 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (2)
- EUDAMED e8e7cfdc-b480-4cc4-9cac-e125287f9492 61 fields · synced Jul 25, 2026
- EUDAMED 9edd514c-5951-4741-92f7-9f84617b66a6 61 fields · synced May 18, 2026