Micsafe

FDA UDI

Class II (US FDA UDI)

by Jiangsu Micsafe Medical Tehcnology Co., LTD.

Identity

Trade Name: Micsafe FDA UDI
Generic Name: General-purpose syringe/needle FDA UDI
Device Name: 10ML LUER SLIP WITH NEEDLE 21G*1 1/2 FDA UDI
Model / Reference: 1 FDA UDI
Description: 10ML LUER SLIP WITH NEEDLE 21G*1 1/2 FDA UDI

Identifiers

Primary DI / UDI-DI: 06971911295103 FDA UDI
FDA Product Code: FMI FDA UDI
MEG FDA UDI
FMF FDA UDI
GMDN Term: General-purpose syringe/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General-purpose syringe/needle

Micsafe by Jiangsu Micsafe Medical Tehcnology Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
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 (1)

FDA UDI 1195bce0-27d4-400a-ad8c-4e1dc44d4560 33 fields · synced Jun 7, 2026