Identity
- Trade Name
- Kitazato ReproPlate-K2 FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- Plasticware EUDAMED1 Packs FDA UDI
- Model / Reference
- 83017 EUDAMEDReproPlate-K2 FDA UDI
- Description
- 1 Packs FDA UDI
Identifiers
- Catalog Number
- 83017 FDA UDI
- Primary DI / UDI-DI
- 04582231462186 EUDAMEDFDA UDI
- Basic UDI-DI
- 458223146PLWL5 EUDAMED
- FDA Product Code
- PUD FDA UDI
- EMDN Code
- U080207 CONTAINERS FOR PREPARATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- IVF medium kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6160 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
Plasticware 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 | 458223146PLWL5 | 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 94b1c4cf-6561-4596-9258-0d41d9eed500 61 fields · synced Jun 18, 2026
- FDA UDI e2ed4d9b-587e-4d6a-a06d-53686301595a 35 fields · synced May 30, 2026