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DropSafe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 49503Model type 820Ref 8161Ref 8393Ref DropSafeRef 8298Ref 8394Ref 8162
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 EUDAMED49503 EUDAMED8161 EUDAMED8393 EUDAMEDDropSafe EUDAMED8298 EUDAMED8394 EUDAMED8162 EUDAMED31G x 5mm 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
- 8161 FDA UDI
- Primary DI / UDI-DI
- 08012992495032 EUDAMED05907996098583 EUDAMEDFDA UDI05903999600914 EUDAMED08012992495049 EUDAMED05903999600815 EUDAMED05903999600921 EUDAMEDD-05907996091584XT EUDAMED
- Basic UDI-DI
- 590799609820MU EUDAMEDB-05907996091584XT EUDAMEDB-05907996098583 EUDAMED
- 510(k) Number
- K211716 FDA UDI
- 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
- Austria EUDAMEDNetherlands EUDAMEDGermany EUDAMEDFinland EUDAMEDFrance 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 — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 590799609820MU | Class IIa | Active |
| 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 (9)
- EUDAMED e6d86622-2acd-4db8-af2a-e4ff81b83b07 61 fields · synced Aug 2, 2026
- EUDAMED 45d03cb9-a65a-4a68-85fd-7f969ef4ca5a 61 fields · synced May 17, 2026
- EUDAMED 37f4994c-700f-4688-8d77-5b632681e5b1 61 fields · synced May 17, 2026
- EUDAMED 313bbff4-5e01-4789-b1d2-3cb18392d73a 61 fields · synced May 18, 2026
- EUDAMED f5eff2e6-22d3-40f6-a510-306bbfc5e642 61 fields · synced May 18, 2026
- FDA UDI 5ee4858f-d199-4263-b3ac-2dc07b4fa0c6 36 fields · synced May 30, 2026
- EUDAMED 4e431f77-3e45-4d6e-8c7b-1f6414d1d633 61 fields · synced Jul 9, 2026
- EUDAMED 9b2b4eda-ad84-4547-b8bd-83f6a61f0584 61 fields · synced Jul 26, 2026
- EUDAMED da9a5510-eaff-4a7d-80cf-b4ea90010a24 61 fields · synced Jul 30, 2026