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Micsafe
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ISY05F31516Model 0.5ml 31G*5/16
Identity
- Trade Name
- Syringe for Insulin EUDAMEDMicsafe FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- Syringe for Insulin EUDAMED0.5ML INSULIN SYRINGE 31G*5/16” FDA UDI
- Model / Reference
- 0.5ml 31G*5/16 EUDAMEDISY05F31516 EUDAMED1 FDA UDI
- Description
- 0.5ML INSULIN SYRINGE 31G*5/16” FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971911296513 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971911296513 EUDAMED
- FDA Product Code
- FMF FDA UDIMEG FDA UDI
- EMDN Code
- A02010602 INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE EUDAMED
- GMDN Term
- Insulin syringe/needle, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 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: Insulin syringe/needle, basic
Micsafe by Jiangsu Micsafe Medical Tehcnology Co., LTD. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, basic.
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- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Micsafe Medical Tehcnology Co., LTD.
Sources (2)
- FDA UDI 471af502-5e4c-43bb-89ff-98e63e4bf54d 33 fields · synced Jul 11, 2026
- EUDAMED 246cc92a-5490-4ceb-a77b-a7145f337f1e 61 fields · synced Jul 11, 2026