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Plasticware

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 83002

by Kitazato Corporation

Identity

Trade Name
35mm Dish FDA UDI
Generic Name
IVF medium kit FDA UDI
Device Name
Plasticware EUDAMED
Model / Reference
83002 EUDAMED
35mm Dish FDA UDI

Identifiers

Primary DI / UDI-DI
04582231462728 EUDAMEDFDA UDI
Basic UDI-DI
458223146PLWL5 EUDAMED
FDA Product Code
MQK FDA UDI
EMDN Code
U080206 CULTURE PLATES FOR ASSISTED REPRODUCTION EUDAMED
GMDN Term
IVF medium kit FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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

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

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

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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 f948f059-2182-4d19-b388-84e618ec13c4 61 fields · synced Jul 12, 2026
  • FDA UDI 147f9476-220a-40d7-bc7b-b9210a316c4c 33 fields · synced May 30, 2026