Surelock
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- VITRIFICATION STRAW EUDAMEDSURELOCK FDA UDI
- Generic Name
- Assisted reproduction vitrification carrier FDA UDI
- Device Name
- VITRIFICATION STRAW EUDAMEDSURELOCK Vitrification Straw - Green colour FDA UDI
- Model / Reference
- SureStrip Vitrification Straw,SureLock Vitrification straw,SureStrip Vitrification Straw weighted,Sure Strip Vitrification Straw weighted plug EUDAMEDSUL-G EUDAMEDSURELOCK Vitrification Straw FDA UDI
- Description
- SURELOCK Vitrification Straw - Green colour FDA UDI
Identifiers
- Catalog Number
- SUL-G FDA UDI
- Primary DI / UDI-DI
- 00819374021692 EUDAMEDFDA UDI
- Basic UDI-DI
- 081226101VSW08834 EUDAMED
- 510(k) Number
- K203626 FDA UDI
- FDA Product Code
- MQK FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Assisted reproduction vitrification carrier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Assisted reproduction vitrification carrier
Surelock by Allwin Medical Devices, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Allwin Medical Devices, Inc.
Sources (2)
- FDA UDI 923482bc-f077-4697-86d6-fd3289393141 36 fields · synced Jun 18, 2026
- EUDAMED f0e1c775-9f13-4d50-a2a5-fb10d41f1d92 61 fields · synced Jun 18, 2026