← Back to catalogue
Ostomy Bag
EUDAMEDFDA UDIClass I (EU MDR)
Ref N/AModel One-piece Ostomy Bag, Two-piece Ostomy Bag
Identity
- Trade Name
- Konweda FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, open-ended FDA UDI
- Device Name
- Ostomy Bag EUDAMED
- Model / Reference
- One-piece Ostomy Bag, Two-piece Ostomy Bag EUDAMEDN/A EUDAMEDOne-piece Ostomy Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975820130012 EUDAMEDFDA UDI
- Basic UDI-DI
- 697582013OB001DQ EUDAMED
- FDA Product Code
- FON FDA UDI
- EMDN Code
- A1001010101,A1001010102,A1001010201,A1001010202,A1001020101,A1001020102,A1001020201,A1001020202,A1001030101,A1001030102,A1001030201,A1001030202 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
- Austria 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ostomy Bag by Dongguan Kangda Medical Technology Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697582013OB001DQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DongGuan Kangda Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000025834
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED fb7283b9-7e86-47ab-b1e9-0803aa23a2fb 61 fields · synced Jun 18, 2026
- FDA UDI ece73d2f-7328-42c2-9d5b-79e3f1abc2fe 32 fields · synced May 25, 2026
- EUDAMED fb7283b9-7e86-47ab-b1e9-0803aa23a2fb-1 61 fields · synced Jun 10, 2026