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Defendo Single Use Valve Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4000096Model Defendo Valves Kit
Identity
- Trade Name
- DEFENDO SINGLE USE VALVE KIT EUDAMEDFDA UDI
- Generic Name
- Endoscope flushing adaptor, single-use FDA UDI
- Device Name
- Defendo Valves Kit EUDAMEDDEFENDO SINGLE USE VALVE KIT- Cleaning Adapter FDA UDI
- Model / Reference
- Defendo Valves Kit EUDAMED4000096 EUDAMEDFDA UDI
- Description
- DEFENDO SINGLE USE VALVE KIT- Cleaning Adapter FDA UDI
Identifiers
- Catalog Number
- 4000096 FDA UDI
- Primary DI / UDI-DI
- 00724995246846 EUDAMED40677964001367 FDA UDI
- Basic UDI-DI
- 0724995CODEFENDVLKITF8 EUDAMED
- 510(k) Number
- K243075 FDA UDI
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
- GMDN Term
- Endoscope flushing adaptor, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0724995CODEFENDVLKITF8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medivators Inc.
- EUDAMED SRN
- US-MF-000043422
- Authorised Representative
- STERIS Ireland Ltd IE-AR-000010065
Sources (2)
- EUDAMED 53f0f259-48d6-4e83-9b24-9c618035bf6c 61 fields · synced Jul 15, 2026
- FDA UDI ab270fe2-9b90-45fa-81ef-5c8def830236 36 fields · synced May 30, 2026