Bial

FDA UDI

Class II (US FDA UDI)

by Jiangsu Micsafe Medical Tehcnology Co., LTD.

Identity

Trade Name: BIAL FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: 5ML LUER SLIP FDA UDI
Model / Reference: 1 FDA UDI
Description: 5ML LUER SLIP FDA UDI

Identifiers

Primary DI / UDI-DI: 06971911291105 FDA UDI
FDA Product Code: FMI FDA UDI
MEG FDA UDI
GMDN Term: General-purpose syringe, single-use 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

Yes

FDA UDI

Category: General-purpose syringe, single-use

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

Similar devices

Also classified as General-purpose syringe, single-use.

Merit Medical® — Merit Medical Systems, Inc. · Class II
SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
SURGYCO — Surgyco LLC · Class I
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
SURGYCO — Surgyco LLC · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Jiangsu Micsafe Medical Tehcnology Co., LTD.

Sources (1)

FDA UDI 1049adab-879f-4b59-8b8c-343b21274d23 33 fields · synced Jun 8, 2026