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SURELOCK Vitrification Straw

by Allwin Medical Devices, Inc. 5 variants

Ref SUL-PModel SureStrip Vitrification Straw,SureLock Vitrification straw,SureStrip Vitrification Straw weighted,Sure Strip Vitrification Straw weighted plug

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081226101VSW08834 Basic UDI-DI 00819374021678UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00819374021678 UDI-DI Date9 Jan 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Vitrification Straw EUDAMED
Surelock GUDID
Generic Name
Assisted reproduction vitrification carrier
Model / Ref / Catalog
SureStrip Vitrification Straw, SureLock Vitrification straw, SureStrip Vitrification Straw weighted, Sure Strip Vitrification Straw weighted plug, SUL-P
Primary DI / UDI-DI
00819374021678
Basic UDI-DI
081226101VSW08834
510(k) Number
FDA Product Code
MQK
EMDN Code
U080299 Devices for assisted reproduction - other
GMDN Term
Assisted reproduction vitrification carrier
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
884.6160
EU market of registration
Lithuania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K203626)

Other devices from Allwin Medical Devices, Inc.

See all devices from Allwin Medical Devices, Inc. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No