Identity
- Trade Name
- droplet EUDAMED
- Device Name
- Pen needle EUDAMED
- Model / Reference
- Type 810 EUDAMED4032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999607258 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
- Poland 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
Introducing the Droplet, a revolutionary medical device that provides precise and sterile needle insertion for various procedures. Designed to meet the highest standards of hygiene and safety, the Droplet is an essential tool in healthcare settings.
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 (1)
- EUDAMED 020fccaf-f543-454d-8b9f-2457a7a9a755 61 fields · synced Jul 4, 2026