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DEFENDO Disposable Biopsy Valve
EUDAMEDFDA UDIClass I (EU MDR)
Ref 100302Model Defendo Valves
Identity
- Trade Name
- DEFENDO Disposable Biopsy Valve EUDAMEDFDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Defendo Valves EUDAMEDDEFENDO Disposable Biopsy Valve for PENTAX GI Endoscopes FDA UDI
- Model / Reference
- Defendo Valves EUDAMED100302 EUDAMEDFDA UDI
- Description
- DEFENDO Disposable Biopsy Valve for PENTAX GI Endoscopes FDA UDI
Identifiers
- Catalog Number
- 100302 FDA UDI
- Primary DI / UDI-DI
- 00724995246709 EUDAMED00677964060267 FDA UDI
- Basic UDI-DI
- 0724995CODEFENDOVALVEH4 EUDAMED
- 510(k) Number
- K090851 FDA UDI
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
- GMDN Term
- Endoscope channel support kit 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DEFENDO Disposable Biopsy Valve 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0724995CODEFENDOVALVEH4 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0724995CODEFENDOVALVEH4 | 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 f228f926-ce84-4153-b063-b399b04d67cc 61 fields · synced May 31, 2026
- FDA UDI 6aab2ab3-a065-4301-98ce-9c4ebcb9e066 36 fields · synced May 30, 2026