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Droplet
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 81012610101000Model PEN NEEDLE
by Pikdare Spa
Identity
- Trade Name
- DROPLET EUDAMEDFDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- PEN NEEDLE 30GX8MM FDA UDI
- Model / Reference
- PEN NEEDLE EUDAMED81012610101000 EUDAMED02022987000100 FDA UDI
- Description
- PEN NEEDLE 30GX8MM FDA UDI
Identifiers
- Catalog Number
- 02022987000100 FDA UDI
- Primary DI / UDI-DI
- 08058090054931 EUDAMED00812383030600 FDA UDI
- Basic UDI-DI
- 8058090PN310000ES EUDAMED
- 510(k) Number
- K051783 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O 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
- Italy 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
Yes
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
Category: Autoinjector needle
Droplet by Pikdare Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Autoinjector needle.
- Unifine Ultra — OWEN MUMFORD USA INCORPORATED · Class II
- MICRON, droplet pen needle — HTL STREFA S A · Class II
- SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
- EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
- droplet®, pen needles — HTL STREFA S A · Class II
- Nano 2nd Gen — embecta Medical II LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
- Insulin Pen Needle — Berpu Medical Technology Co., Ltd · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pikdare Spa
Sources (2)
- FDA UDI 6745edbc-22d4-49f3-a041-630fd1d2291c 38 fields · synced Sep 17, 2026
- EUDAMED 82659e1a-2444-462d-9eb2-ddf4d51d107f 61 fields · synced Sep 17, 2026