Identity
- Trade Name
- Syringe for Insulin EUDAMEDMicsafe FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Syringe for Insulin EUDAMED1ml insulin syringe with 31G*1/2 FDA UDI
- Model / Reference
- 1ml 31G*1/2" EUDAMEDISY1F3112 EUDAMED1 FDA UDI
- Description
- 1ml insulin syringe with 31G*1/2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971911296506 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971911296506 EUDAMED
- FDA Product Code
- FMI FDA UDIMEG FDA UDIFMF FDA UDI
- EMDN Code
- A02010602 INSULIN SYRINGES W/O FIXED NEEDLES, SINGLE-USE EUDAMED
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 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: General-purpose syringe/needle
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 General-purpose syringe/needle.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
- CarePoint Precision — ALLISON MEDICAL, INC. · Class II
- YI XIN Sterile Syringe For Single Use — Jiang Xi Sanxin Medtec Co., Ltd. · Class II
- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
- Azur Medical Company Inc. — Azur Medical Company, Inc. · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- CarePoint Precision — ALLISON MEDICAL, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Micsafe Medical Tehcnology Co., LTD.
Sources (2)
- FDA UDI 769fdbd1-a52c-4ffb-89c9-407b474965e6 33 fields · synced Jul 11, 2026
- EUDAMED 9ce49014-2c76-44c9-98e9-42cd2469321a 61 fields · synced Jul 11, 2026