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micsafe
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ISY05F30516Model 0.5ml 30*5/16”
Identity
- Trade Name
- Syringe for Insulin EUDAMEDmicsafe FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- Syringe for Insulin EUDAMEDINSULIN SYRINGE 0.5ML 30*8mm FDA UDI
- Model / Reference
- 0.5ml 30*5/16” EUDAMEDISY05F30516 EUDAMED1 FDA UDI
- Description
- INSULIN SYRINGE 0.5ML 30*8mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971911296520 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971911296520 EUDAMED
- 510(k) Number
- K202570 FDA UDI
- FDA Product Code
- FMI 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
- 880.5570 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
Yes
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.
- EasyTouch — MHC Medical Products · Class II
- EasyTouch — MHC Medical Products · Class II
- BH Supplies — ANREL DISTRIBUTION LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON AND COMPANY · Class II
- droplet insulin syringes — HTL STREFA S A · Class II
- Insulin Syringe — Dynarex Corp. · Class II
- LiteTouch — AMITY HOLDINGS, LLC · Class II
- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Cleared under the same submission
K202570 also covers:
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
- RELI — MYCO MEDICAL SUPPLIES INC.
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 3ae07c17-d35f-415d-9705-f2044cde66c6 34 fields · synced Jun 18, 2026
- EUDAMED b14fa124-34e9-4dc0-9937-19cd7634ee8b 61 fields · synced Jun 18, 2026