One-Piece Urostomy Bag
by Concarey Medical Technology Co., Ltd China EUDAMED
Ref 63315Model 63226,63228,63307,63309,53201,53202,63315,63316,13203,13303,5985K,5985L,5985G,14103,15202E,15202H,14222,14222G,16810A,16810G,5585,5585G,61003,63005,63006,63013,63014,63103,63104,53001,53003,63105,63106,13003,13103,10451,13005
EMDN A1001030201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6975700081POstomyBagCX | Date7 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- One-Piece Ostomy Bag
- Model / Reference
- 63226, 63228, 63307, 63309, 53201, 53202, 63315, 63316, 13203, 13303, 5985K, 5985L, 5985G, 14103, 15202E, 15202H, 14222, 14222G, 16810A, 16810G, 5585, 5585G, 61003, 63005, 63006, 63013, 63014, 63103, 63104, 53001, 53003, 63105, 63106, 13003, 13103, 10451, 13005
- Primary DI / UDI-DI
- 06975700085579
- Basic UDI-DI
- 6975700081POstomyBagCX
- EMDN Code
- A1001030201 One-piece urostomy bags for retracted stoma, convex, 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 21beedd0-8aa5-4210-b92e-529f0a5ffde3