Identity
- Trade Name
- DropSafe EUDAMEDDropSafe, safety pen needles FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Safety pen needle EUDAMED100 pcs sterile single use DropSafe pen needles per box, intended for use with pen injector devices for the injection of drugs. FDA UDI
- Model / Reference
- type 820 EUDAMED8162 EUDAMED31G x 6mm FDA UDI
- Description
- 100 pcs sterile single use DropSafe pen needles per box, intended for use with pen injector devices for the injection of drugs. FDA UDI
Identifiers
- Catalog Number
- 8162 FDA UDI
- Primary DI / UDI-DI
- 05907996091584 EUDAMEDFDA UDI
- Basic UDI-DI
- 590799609820MU EUDAMED
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DropSafe by Htl Strefa S A — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 590799609820MU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (2)
- EUDAMED 555c4a43-f929-4450-9410-2430357635df 61 fields · synced Jun 20, 2026
- FDA UDI 01788b02-29ca-4a1f-9f2a-c9e5a23e1912 35 fields · synced May 30, 2026