Harmony Duo Pouches
by Salts Healthcare Ltd EUDAMED
Active
Ref HDCM1370
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5035706COLO2PPH | Date24 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- HDCM1370
- Primary DI / UDI-DI
- 05035706057329
- Basic UDI-DI
- 5035706COLO2PPH
- EMDN Code
- A10020202 Colostomy bags for two-part systems, with tissue cover
- Device Class
- Class I
- Market of Registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000004531
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Salts Healthcare Limited
Properties
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