Identity
- Trade Name
- DEWIN FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures. FDA UDI
- Model / Reference
- 9340 FDA UDI
- Description
- Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972962312436 FDA UDI
- 510(k) Number
- K212426 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: IVF medium
Dewin by DonneVie Medical Technology(Shanghai)Co.Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212426 also covers:
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd
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
- DonneVie Medical Technology(Shanghai)Co.Ltd
Sources (1)
- FDA UDI bc83c264-fde8-4a6e-ad8f-e98946229dc0 34 fields · synced Jun 1, 2026