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DiLumen C1, 130 cm

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref D-2100

by Lumendi Llc

Identity

Trade Name
DiLumen C1 !30 cm EUDAMED
DiLumen C1, 130 cm FDA UDI
Generic Name
Colonoscope positioning sleeve FDA UDI
Device Name
DiLumen Endoluminal Interventional Platform EUDAMED
The Lumendi DiLumen C1 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 C1 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. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions. FDA UDI
Model / Reference
D-2100 EUDAMED
DiLumen C1, 130 cm FDA UDI
Description
The Lumendi DiLumen C1 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 C1 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. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions. FDA UDI

Identifiers

Catalog Number
D-2100 FDA UDI
Primary DI / UDI-DI
00858836007164 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 EUDAMED
Class 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

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

Category: Colonoscope positioning sleeve

DiLumen C1, 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.

Cleared under the same submission

K221452 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lumendi Llc

Sources (2)

  • FDA UDI 146cd293-3fb8-43f7-be6c-37909fed1921 36 fields · synced Aug 1, 2026
  • EUDAMED 58b6ceba-2675-4fb2-a78d-99c16332ed2e 61 fields · synced Aug 1, 2026