Surestrip

FDA UDI

Class II (US FDA UDI)

by Allwin Medical Devices, Inc.

Identity

Trade Name: SURESTRIP FDA UDI
Generic Name: Assisted reproduction vitrification carrier FDA UDI
Device Name: SURESTRIP Vitrification Straw - Red colour FDA UDI
Model / Reference: SURESTRIP Vitrification Straw FDA UDI
Description: SURESTRIP Vitrification Straw - Red colour FDA UDI

Identifiers

Catalog Number: SUS-R FDA UDI
Primary DI / UDI-DI: 00819374021722 FDA UDI
510(k) Number: K203626 FDA UDI
FDA Product Code: MQK FDA UDI
GMDN Term: Assisted reproduction vitrification carrier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6160 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

Yes

FDA UDI

Category: Assisted reproduction vitrification carrier

Surestrip by Allwin Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K203626 also covers:

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: Allwin Medical Devices, Inc.

Sources (1)

FDA UDI e4b531e3-4f14-4014-9f0a-96f19144f26a 36 fields · synced Jun 8, 2026