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Micronjet
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 600Model Micronjet600510(k) K092746
Identity
- Trade Name
- Micronjet EUDAMEDMicronJet 600 FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Micronjet EUDAMEDA female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.6 mm (600 micron) in length (height). This device can be mounted on any standard syringe (luer slip or luer lock connection) FDA UDI
- Model / Reference
- Micronjet600 EUDAMED600 EUDAMEDS4013_1 FDA UDI
- Description
- A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.6 mm (600 micron) in length (height). This device can be mounted on any standard syringe (luer slip or luer lock connection) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290015928226 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001592803C3 EUDAMED
- 510(k) Number
- K092746 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
- GMDN Term
- Hypodermic needle, single-use 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
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
Dimensions & Sizes
- Size
- Length — 600 Micrometer FDA UDI
Micronjet by Nanopass Technologies Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092746 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 729001592803C3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- NanoPass Technologies Ltd.
- EUDAMED SRN
- IL-MF-000023415
- FDA Applicant
- Nanopass Technologies , Ltd.
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 6a3ea49e-966a-48d3-9554-010b399e1a97 85 fields · synced Jun 18, 2026
- FDA UDI 9d5a3d94-e149-4f16-9114-1c6083349ccf 36 fields · synced May 30, 2026
- FDA 510(k) K092746 1 fields · synced May 18, 2026