Identity
- Trade Name
- DEWIN FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Dewin Cleavage Medium [ without HSA],25mL. FDA UDI
- Model / Reference
- 9326 FDA UDI
- Description
- Dewin Cleavage Medium [ without HSA],25mL. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972962312177 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
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: IVF medium
Dewin by DonneVie Medical Technology(Shanghai)Co.Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as IVF medium.
- SPERMCARE Upper Layer - Gradient System — INVITROCARE, INCORPORATED · Class II
- Sepa Sperm Solution — KITAZATO CORPORATION · Class II
- LifeGlobal® Media — LifeGlobal Group, LLC · Class II
- Multipurpose Handling Medium®-Complete (MHM®-C) — FUJIFILM IRVINE SCIENTIFIC, INC. · Class II
- CaseBioscience® — Casebioscience, Inc. · Class II
- SpermFreeze SSP — Fertipro NV · Class II
- Gems Blastocyst Medium — GENEA BIOMEDX PTY LTD · Class II
- Sperm Freezing Medium — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DonneVie Medical Technology(Shanghai)Co.Ltd
Sources (1)
- FDA UDI 41194ae2-ad3a-45ff-b051-712617bb2ac1 34 fields · synced May 31, 2026