Identity
- Trade Name
- KD-PENOFINE S EUDAMED
- Device Name
- KD-PENOFINE S Pen Needles EUDAMED
- Model / Reference
- 920008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24031881920002 EUDAMED
- Basic UDI-DI
- 4031881G10-02bIIaV4 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Kd-Penofine S by KD Medical GmbH Hospital Products — 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 | 4031881G10-02bIIaV4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- KD Medical GmbH Hospital Products
- EUDAMED SRN
- DE-MF-000006773
Sources (1)
- EUDAMED 5c4cf0a4-aa0c-496b-87dc-ad30ace1555c 61 fields · synced Jun 18, 2026