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SureStrip Vitrification Straw
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SUS-BModel SureStrip Vitrification Straw,SureLock Vitrification straw,SureStrip Vitrification Straw weighted,Sure Strip Vitrification Straw weighted plug510(k) K203626Ref SUS-B-WTPRef SUS-B-WTRef SUL-P
Identity
- Trade Name
- SureStrip Vitrification Straw EUDAMEDVITRIFICATION STRAW EUDAMEDSURELOCK FDA UDISURESTRIP FDA UDI
- Generic Name
- Assisted reproduction vitrification carrier FDA UDI
- Device Name
- VITRIFICATION STRAW EUDAMEDSURELOCK Vitrification Straw - Pink colour FDA UDISURESTRIP Vitrification Straw - Blue colour FDA UDI
- Model / Reference
- SureStrip Vitrification Straw,SureLock Vitrification straw,SureStrip Vitrification Straw weighted,Sure Strip Vitrification Straw weighted plug EUDAMEDSUS-B EUDAMEDSUS-B-WTP EUDAMEDSUS-B-WT EUDAMEDSUL-P EUDAMEDSURELOCK Vitrification Straw FDA UDISURESTRIP Vitrification Straw FDA UDI
- Description
- SURELOCK Vitrification Straw - Pink colour FDA UDISURESTRIP Vitrification Straw - Blue colour FDA UDI
Identifiers
- Catalog Number
- SUL-P FDA UDISUS-B FDA UDI
- Primary DI / UDI-DI
- 00819374021555 EUDAMEDFDA UDI00819374021678 EUDAMEDFDA UDI00819374026963 EUDAMED00819374023979 EUDAMED
- Basic UDI-DI
- 081226101VSW08834 EUDAMED
- Direct Marketing DI
- 00819374021555 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
- Lithuania EUDAMEDDenmark EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assisted reproduction vitrification carrier
SureStrip Vitrification Straw by Allwin Medical Devices, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203626 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081226101VSW08834 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc
- EUDAMED SRN
- US-MF-000011349
- FDA Applicant
- Allwin Medical Devices, Inc.
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (8)
- EUDAMED a32f98d0-087e-4401-a07a-132218458935 85 fields · synced Sep 18, 2026
- FDA UDI ee35c580-9fdd-4e3e-a175-fcd9140d79a4 36 fields · synced May 30, 2026
- FDA UDI c2269e6e-948d-444a-9ba8-0efb3fe6babb 36 fields · synced May 30, 2026
- EUDAMED b857980a-8ca1-4f7e-8269-72e4d18a3639 61 fields · synced Jun 19, 2026
- EUDAMED d93a608f-a770-4da9-b673-0dcc2899f635 61 fields · synced Jul 11, 2026
- EUDAMED a3b3d835-6f94-411f-819a-f2a3f90505a2 61 fields · synced Jul 13, 2026
- EUDAMED 256e7370-3adf-428f-aef8-db7c1936ba1d 61 fields · synced Sep 18, 2026
- FDA 510(k) K203626 1 fields · synced May 18, 2026