IMPROSAFE® Blood Collection Set with Pre-Attached Holder

FDA UDIEUDAMED

Class II (US FDA UDI)

by Guangzhou Improve Medical Instruments Co., Ltd.

Identity

Trade Name: IMPROSAFE® Blood Collection Set with Pre-Attached Holder FDA UDI
Generic Name: Non-fixed blood collection needle FDA UDI
Model / Reference: 23G x 3/4” x 7” FDA UDI

Identifiers

Primary DI / UDI-DI: 06933395620697 FDA UDI
510(k) Number: K153388 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Non-fixed blood collection needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 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

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: Non-fixed blood collection needle

IMPROSAFE® Blood Collection Set with Pre-Attached Holder by Guangzhou Improve Medical Instruments Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID…

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Cleared under the same submission

K153388 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Guangzhou Improve Medical Instruments Co., Ltd.

Sources (2)

FDA UDI 308f3c6d-966f-499c-b719-5a9f3b2f7fa5 33 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 29, 2026