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SenSura Mio

FDA UDI

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
SenSura Mio FDA UDI
Generic Name
Multiple-piece intestinal ostomy bag, open-ended FDA UDI
Model / Reference
18656 FDA UDI

Identifiers

Catalog Number
18656 FDA UDI
Primary DI / UDI-DI
05701780003216 FDA UDI
FDA Product Code
EXB FDA UDI
GMDN Term
Multiple-piece intestinal ostomy bag, open-ended FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 70 Millimeter FDA UDI

Category: Multiple-piece intestinal ostomy bag, open-ended

At SenSura Mio, we've developed a revolutionary single-use intestinal ostomy bag designed to provide a secure and comfortable solution for individuals undergoing surgical removal of the colon or rectum. Our innovative design features a unique flange-locking mechanism that ensures a snug fit around the stoma, while also allowing for easy drainage and emptying.

Similar devices

Also classified as Multiple-piece intestinal ostomy bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 85edb669-7c89-42de-8245-03e2c518ca3a 35 fields · synced Jul 21, 2026