Identity
- Trade Name
- SenSura EUDAMEDFDA UDI
- Generic Name
- One-piece intestinal ostomy bag, open-ended FDA UDI
- Device Name
- SenSura Post op ostomy bag 1-piece sterile EUDAMED
- Model / Reference
- 19011 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 19011 FDA UDI
- Primary DI / UDI-DI
- 05708932972901 EUDAMED05708932135085 FDA UDI
- Basic UDI-DI
- 57089322976228U EUDAMED
- Unit of Use DI
- 05708932135085 EUDAMED
- FDA Product Code
- EXB FDA UDI
- EMDN Code
- A1001010102,A1001020102 EUDAMED
- GMDN Term
- One-piece intestinal ostomy bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: One-piece intestinal ostomy bag, open-ended
SenSura by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (2)
- FDA UDI 30e1d3a6-7ce0-4104-a1b1-5488e5ee7c3d 35 fields · synced Oct 7, 2026
- EUDAMED 06411563-dbaf-482e-a701-41c6d80b3cac 61 fields · synced Oct 7, 2026