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SenSura Click
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 19731Ref 19748Ref 19745Ref 19749Ref 19732Ref 19746Ref 19742Ref 11844Ref 10036Ref 110220Ref 14884Ref 118510Ref 19729
Identity
- Trade Name
- SenSura Click EUDAMEDFDA UDI
- Generic Name
- Multiple-piece intestinal ostomy bag, closed-ended FDA UDIIntestinal ostomy base plate, flat FDA UDIMultiple-piece urostomy bag, open-ended FDA UDI
- Device Name
- SenSura Mio click ostomy bag 2-piece closed EUDAMEDSenSura Mio click ostomy bag 2-piece open EUDAMEDSenSura Click urostomy bag 2-piece EUDAMEDSenSura Click Xpro ostomy baseplate EUDAMEDSenSura Click ostomy baseplate convex EUDAMEDSenSura Click ostomy bag 2-piece open EUDAMEDSenSura Click . Coupling Size Diameter 60 mm, Coupling Size Diameter 2 3/8 in, Base Plate Precut Start Hole Size 40 mm, Base Plate Max Cut Size 55 mm, Baseplate Precut Start Hole Size 1 5/8 in, Base Plate Type Flat. FDA UDI
- Model / Reference
- 10036 EUDAMEDFDA UDI11844 EUDAMEDFDA UDI19731 EUDAMED19748 EUDAMED19745 EUDAMED19749 EUDAMED19732 EUDAMED19746 EUDAMED19742 EUDAMED110220 EUDAMED14884 EUDAMED118510 EUDAMED19729 EUDAMED10156 FDA UDI
- Description
- SenSura Click . Coupling Size Diameter 60 mm, Coupling Size Diameter 2 3/8 in, Base Plate Precut Start Hole Size 40 mm, Base Plate Max Cut Size 55 mm, Baseplate Precut Start Hole Size 1 5/8 in, Base Plate Type Flat. FDA UDI
Identifiers
- Catalog Number
- 10156 FDA UDI10036 FDA UDI11844 FDA UDI
- Primary DI / UDI-DI
- 05701780378376 EUDAMED05701780378802 EUDAMED05701780378628 EUDAMED05701780378833 EUDAMED05701780378444 EUDAMED05701780378680 EUDAMED05701780378529 EUDAMED05708932401593 EUDAMED05708932405812 EUDAMED05708932339797 EUDAMED05708932450102 EUDAMED05708932397292 EUDAMED05701780378239 EUDAMED00762123053430 FDA UDI05708932408677 FDA UDI05708932421997 FDA UDI
- Basic UDI-DI
- 57089322975078T EUDAMED570893229753896 EUDAMED57089322975759C EUDAMED57089322976038Q EUDAMED57089322976018L EUDAMED57089322975448Z EUDAMED
- Unit of Use DI
- 05701780378420 EUDAMED05701780378826 EUDAMED05701780378673 EUDAMED05701780378857 EUDAMED05701780378482 EUDAMED05701780378710 EUDAMED05701780378581 EUDAMED05701780075596 EUDAMED05708932964692 EUDAMED05701780059541 EUDAMED05701780123778 EUDAMED05701780077033 EUDAMED05701780378260 EUDAMED
- FDA Product Code
- EXB FDA UDI
- EMDN Code
- A10020202 COLOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMEDA10020302 ILEOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMEDA10020402 UROSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMEDA1002010401 UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH NON-INTROFLEX STOMA EUDAMEDA1002010402 UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH INTROFLEX STOMA EUDAMEDA10020202,A10020302 EUDAMED
- GMDN Term
- Multiple-piece intestinal ostomy bag, closed-ended FDA UDIIntestinal ostomy base plate, flat FDA UDIMultiple-piece urostomy bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Market of Registration
- Italy EUDAMEDIreland EUDAMEDGermany EUDAMEDSweden EUDAMEDFinland EUDAMEDAustria 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
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 60 Millimeter FDA UDILumen/Inner Diameter — 40 Millimeter FDA UDI
Category: Multiple-piece intestinal ostomy bag, closed-ended
SenSura Click by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Multiple-piece intestinal ostomy bag, closed-ended.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (16)
- FDA UDI 4aa148c3-c9b3-4fe5-9bf2-f593792f9a7b 35 fields · synced Sep 30, 2026
- FDA UDI d6ad800e-901f-4dbd-9fa9-39c8a89512f0 36 fields · synced May 30, 2026
- FDA UDI 3811d919-12b3-402b-9905-7ee486675cf1 35 fields · synced May 30, 2026
- EUDAMED 2f218308-8e07-483d-8052-146498fd8929 61 fields · synced Jul 10, 2026
- EUDAMED 918d2b3c-83a4-4ec3-86c1-9a53f1e22562 61 fields · synced Jul 11, 2026
- EUDAMED 76bce298-a569-4b51-8fd8-3af4aa5d45ec 61 fields · synced Jul 15, 2026
- EUDAMED 5be1b967-fd49-40e8-8195-b6ff5690e57c 61 fields · synced Jul 19, 2026
- EUDAMED 10faa34b-689f-4d47-96b0-92927ccaccac 61 fields · synced Jul 24, 2026
- EUDAMED fd5e6f6a-cb20-4ce2-b424-1fa205f161b1 61 fields · synced Jul 25, 2026
- EUDAMED e9827656-304e-402f-bbc7-559f967b5454 61 fields · synced Jul 26, 2026
- EUDAMED a890a75e-5755-4441-9077-fe9023cde31a 61 fields · synced Aug 1, 2026
- EUDAMED 81ba782c-befc-43ea-bc21-bf92af49af3a 61 fields · synced Aug 1, 2026
- EUDAMED 29e4ab05-ce5f-4268-b9e8-e39397b2eae1 61 fields · synced Aug 1, 2026
- EUDAMED e7458d05-3c6b-4774-a0b5-a96f927e9591 61 fields · synced Aug 1, 2026
- EUDAMED b78ca683-d700-4fec-8068-a531350b51bb 61 fields · synced Sep 17, 2026
- EUDAMED 2234a85c-1061-4b57-ab64-421268ae6a7c 61 fields · synced Sep 17, 2026