Identity
- Trade Name
- Safety Needle EUDAMEDMicsafe FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Safety Needle EUDAMEDSafety Needle 25G*1'' FDA UDI
- Model / Reference
- 25G*1'' EUDAMEDDN2501S EUDAMED1 FDA UDI
- Description
- Safety Needle 25G*1'' FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971911290436 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971911290436 EUDAMED
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH 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
- 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
Yes
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: Hypodermic needle, single-use
Safety Needle by Jiangsu Micsafe Medical Technology Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-06971911290436 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Micsafe Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000011594
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (2)
- EUDAMED 90e843b3-5c5f-496c-9fc4-2ff43ed69602 61 fields · synced Jul 16, 2026
- FDA UDI 5d074532-9b54-4293-9d3b-5313a5545954 33 fields · synced May 30, 2026