Identity
- Trade Name
- DropSafe EUDAMEDDropSafe, safety pen needles FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Safety pen needle EUDAMED3 pcs sterile single use DropSafe pen needles per bag, intended for use with pen injector devices for the injection of drugs. FDA UDI
- Model / Reference
- type 820 EUDAMED8432 EUDAMED31G x 6mm FDA UDI
- Description
- 3 pcs sterile single use DropSafe pen needles per bag, intended for use with pen injector devices for the injection of drugs. FDA UDI
Identifiers
- Catalog Number
- 8432 FDA UDI
- Primary DI / UDI-DI
- 05903999601775 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05903999601775 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
- Germany 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
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
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 — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05903999601775 | 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 8bd1dabb-8867-4050-8cb7-326fac27e021 61 fields · synced May 30, 2026
- FDA UDI 28caae02-915b-4252-a769-a4a14f9cd90c 35 fields · synced May 30, 2026