DiLumen EZ1, 130 cm
FDA UDIEUDAMEDClass II (US FDA UDI)
by Lumendi Llc
Identity
- Trade Name
- DiLumen EZ1 130 cm EUDAMEDDiLumen EZ1, 130 cm FDA UDI
- Generic Name
- Colonoscope positioning sleeve FDA UDI
- Device Name
- DiLumen Endoluminal Interventional Platform EUDAMEDThe Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen EZ1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. FDA UDI
- Model / Reference
- D-1100 EUDAMEDDiLumen EZ1, 130 cm FDA UDI
- Description
- The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen EZ1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. FDA UDI
Identifiers
- Catalog Number
- D-1100 FDA UDI
- Primary DI / UDI-DI
- 00858836007171 EUDAMEDFDA UDI
- Basic UDI-DI
- 08653090002DILUMENB5 EUDAMED
- 510(k) Number
- K221452 FDA UDI
- FDA Product Code
- FDF FDA UDI
- EMDN Code
- G0280 GASTROINTESTINAL TUBES - ACCESSORIES EUDAMED
- GMDN Term
- Colonoscope positioning sleeve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Colonoscope positioning sleeve
DiLumen EZ1, 130 cm by Lumendi Llc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Colonoscope positioning sleeve.
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen C1, 130 cm — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen EZ1, 103 cm — LUMENDI LLC · Class II
- DiLumen Endolumenal Interventional Platform, 103 cm — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
Cleared under the same submission
K221452 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lumendi Llc
Sources (2)
- FDA UDI 7554215a-fa5a-4343-86eb-d6708d86b10b 36 fields · synced Jul 10, 2026
- EUDAMED a903e7d0-7c70-412a-b6f3-b3c1dec3173f 61 fields · synced Jul 10, 2026