Identity
- Trade Name
- Hypure Oil Heavy FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Hypure® Oil EUDAMED1 Packs FDA UDI
- Model / Reference
- 96011 EUDAMEDHypure Oil Heavy FDA UDI
- Description
- 1 Packs FDA UDI
Identifiers
- Catalog Number
- 96011 FDA UDI
- Primary DI / UDI-DI
- 04582231467242 EUDAMEDFDA UDI
- Basic UDI-DI
- 458223146HYPKN EUDAMED
- FDA Product Code
- QKI FDA UDI
- EMDN Code
- U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hypure® Oil by Kitazato Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458223146HYPKN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Kitazato Corporation
- EUDAMED SRN
- JP-MF-000018374
- Authorised Representative
- BIOMEDICAL SUPPLY, S.L. ES-AR-000014358
Sources (2)
- EUDAMED a9be33fa-9dc8-45d1-8ff1-0a610fb56b1f 61 fields · synced Jul 15, 2026
- FDA UDI f46f211d-2986-41fa-85e5-033c7d246777 35 fields · synced May 27, 2026