Two-Piece Drainable Ostomy Bag
by Concarey Medical Technology Co., Ltd China EUDAMED
Ref 10386AModel 71205,71206,10385A,71208,73002,84001,84004,73301,1758,71201,71202,10386A,71204,10386E,73006,1759-N10,11856,84002,73303,71209,71210,10387A,71212,73004
EMDN A10020301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6975700082POstomyBagDW | Date18 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Two-Piece Ostomy Bag
- Model / Reference
- 71205, 71206, 10385A, 71208, 73002, 84001, 84004, 73301, 1758, 71201, 71202, 10386A, 71204, 10386E, 73006, 1759-N10, 11856, 84002, 73303, 71209, 71210, 10387A, 71212, 73004
- Primary DI / UDI-DI
- 06975700083810
- Basic UDI-DI
- 6975700082POstomyBagDW
- EMDN Code
- A10020301 Ileostomy bags for two-part systems, w/o tissue cover
- Device Class
- Class I
- Market of Registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- CN-MF-000035609
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Concarey Medical Technology Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED c94b33c1-26af-4eea-9743-2b98fde3024d