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Plasticware
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 83006Ref 83023Ref 83012Ref 83040Ref 83030Ref 83060Ref 83041Ref 83005
Identity
- Trade Name
- ReproPlate-K1(6Well) FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- Plasticware EUDAMED10 Packs FDA UDI
- Model / Reference
- 83006 EUDAMED83023 EUDAMED83012 EUDAMED83040 EUDAMED83030 EUDAMED83060 EUDAMED83041 EUDAMED83005 EUDAMEDReproPlate-K1(6Well) FDA UDI
- Description
- 10 Packs FDA UDI
Identifiers
- Catalog Number
- 83006 FDA UDI
- Primary DI / UDI-DI
- 04582231462391 EUDAMEDFDA UDI04582231469277 EUDAMED04582231460946 EUDAMED04582231460540 EUDAMED04582231466412 EUDAMED14582231464644 EUDAMED04582231460557 EUDAMED04582231460564 EUDAMED
- Basic UDI-DI
- 458223146PLWL5 EUDAMED
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U080207 CONTAINERS FOR PREPARATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION EUDAMEDU080206 CULTURE PLATES FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- IVF medium kit 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
No
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 (9)
- EUDAMED 8215cde1-67e7-4604-8e09-7bc0dfcc0fb6 61 fields · synced Aug 1, 2026
- EUDAMED a0a48567-4ad7-471b-b411-1852e0ab21c6 61 fields · synced May 16, 2026
- EUDAMED 54148f5e-8590-4ecc-a12d-2cfa01aed474 61 fields · synced May 17, 2026
- EUDAMED a7e42fce-eb74-4841-b86b-c7175465d2c4 61 fields · synced May 17, 2026
- EUDAMED 17cc5179-0ae3-4351-ae9a-d530175265c2 61 fields · synced May 17, 2026
- EUDAMED c32bba68-b62a-456f-9981-844fe10a3106 61 fields · synced May 18, 2026
- EUDAMED 6450b302-d203-4686-8e5b-614bc18c98aa 61 fields · synced May 19, 2026
- EUDAMED 9b528518-1991-48d3-999a-f51f722e48a2 61 fields · synced May 19, 2026
- FDA UDI 60c66a59-d997-4710-8590-e42d603f5168 35 fields · synced May 24, 2026