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SenSura Mio Flex

FDA UDIEUDAMED

Class I (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
SenSura Mio Flex FDA UDI
Generic Name
Intestinal ostomy base plate, convex FDA UDI
Model / Reference
13661 FDA UDI

Identifiers

Catalog Number
13661 FDA UDI
Primary DI / UDI-DI
05701780240673 FDA UDI
FDA Product Code
EXB FDA UDI
GMDN Term
Intestinal ostomy base plate, convex 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

Yes

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
Total Volume — 655 Milliliter FDA UDI

Category: Multiple-piece intestinal ostomy bag, open-endedIntestinal ostomy base plate, convex

SenSura Mio Flex by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Intestinal ostomy base plate, convex.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (2)

  • FDA UDI d4fb03a6-e9d1-4896-ab86-bb9df7cd8422 35 fields · synced Jun 15, 2026
  • EUDAMED 1 fields · synced May 25, 2026