Identity
- Trade Name
- One system colostomy bag EUDAMEDSteadlive FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, open-ended FDA UDI
- Device Name
- One system colostomy bag EUDAMED
- Model / Reference
- 101060 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 16937359411854 EUDAMED16937359412356 FDA UDI
- Basic UDI-DI
- 69373594101060ZD EUDAMED
- Direct Marketing DI
- 16937359411854 EUDAMED
- FDA Product Code
- FON FDA UDI
- EMDN Code
- A1001010101 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER 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
- Romania 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
One system colostomy bag by Wuhan Sitaili Medical Apparatus Development Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69373594101060ZD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wuhan Sitaili Medical Apparatus Development Co., Ltd
- EUDAMED SRN
- CN-MF-000010103
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 155d73e9-ef25-4599-b205-67c476ac8b7f 61 fields · synced Jul 29, 2026
- FDA UDI d76aa54a-aa80-44a9-8e8e-331036150ce3 32 fields · synced May 29, 2026