Identity
- Trade Name
- dropfeel EUDAMED
- Device Name
- Pen needle EUDAMED
- Model / Reference
- Type 810 EUDAMED4093 EUDAMED4095 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999607678 EUDAMED05903999607692 EUDAMED
- Basic UDI-DI
- 590799609810EFH EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
dropfeel by Htl Strefa S A — 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 | 590799609810EFH | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (2)
- EUDAMED 67de03c0-33f6-4870-93a6-5a6db997d3b0 61 fields · synced Jul 10, 2026
- EUDAMED 4087a534-be12-4168-ba41-7d8a8e42044b 61 fields · synced May 18, 2026