Endo SmartCap Fujjifilm Adapter
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Endo SmartCap EUDAMEDEndo SmartCap Fujjifilm Adapter FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, reusable FDA UDI
- Device Name
- Endo Smartcap Tubing EUDAMED
- Model / Reference
- Endo Smartcap Tubing EUDAMED100165CO2EXTU EUDAMED100560 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00724995221454 EUDAMED00677964093326 FDA UDI
- Basic UDI-DI
- B-00724995221454 EUDAMED
- FDA Product Code
- NKC FDA UDI
- EMDN Code
- G020199 GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER EUDAMED
- GMDN Term
- Endoscopic insufflation tubing set, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.1730 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic insufflation tubing set, reusable
Endo SmartCap Fujjifilm Adapter by Medivators Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic insufflation tubing set, reusable.
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- CYLINDER HOSE — Olympus Medical Systems Corporation · Class II
- LOW FLOW GAS TUBE — Olympus Medical Systems Corporation · Class II
- CO2 Source Tubing Adapter (Non-Sterile) — GA Health Company Limited · Class I
- Hydra — Boston Scientific · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medivators Inc.
Sources (2)
- FDA UDI febb4d55-d60d-4c74-ae7d-929cbc4aa384 32 fields · synced Sep 30, 2026
- EUDAMED fe9c0b22-f87b-41ea-9b62-1777688aac70 61 fields · synced Sep 30, 2026