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Defendo Single Use Valve Kit

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 100311Model Defendo Valves Kit

by Medivators Inc.

Identity

Trade Name
Defendo Single Use Valve Kit EUDAMEDFDA UDI
Generic Name
Endoscope channel support kit FDA UDI
Device Name
Defendo Valves Kit EUDAMED
DEFENDO Valve and Connetor Kit 3 piece-kit includes Air Water, Suction and Biopsy Valves and Endogator Connector FDA UDI
Model / Reference
Defendo Valves Kit EUDAMED
100311 EUDAMEDFDA UDI
Description
DEFENDO Valve and Connetor Kit 3 piece-kit includes Air Water, Suction and Biopsy Valves and Endogator Connector FDA UDI

Identifiers

Catalog Number
100311 FDA UDI
Primary DI / UDI-DI
00724995246754 EUDAMED
00677964090912 FDA UDI
Basic UDI-DI
0724995CODEFENDVLKITF8 EUDAMED
510(k) Number
K090851 FDA UDI
K102409 FDA UDI
K102581 FDA UDI
FDA Product Code
ODC FDA UDI
FDF FDA UDI
EMDN Code
A030499 ADMINISTRATION KITS - OTHER EUDAMED
GMDN Term
Endoscope channel support kit FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Ireland 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

Yes

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

No

FDA UDI

Defendo Single Use Valve Kit by Medivators Inc. — Class I — 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
Medivators Inc.
EUDAMED SRN
US-MF-000043422
Authorised Representative
STERIS Ireland Ltd IE-AR-000010065

Sources (2)

  • EUDAMED 4832570d-9912-4076-9a1a-35b10f67cf28 61 fields · synced Jul 10, 2026
  • FDA UDI 8ed46587-cfb4-4720-b657-03f2271828b4 36 fields · synced May 29, 2026