Hydrex
by Fomed Industries Inc. EUDAMED
Active
Ref 17cmx45cm-6Ply
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697368504SBPWXCS01FH | Date28 Mar 2025 | 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- Withdrawn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
- Device Name
- Sterile gauze swabs
- Model / Reference
- 17cmx45cm-6Ply
- Primary DI / UDI-DI
- 06973685042778
- Basic UDI-DI
- 697368504SBPWXCS01FH
- EMDN Code
- M0201020201 Cotton gauzes, folded, with x-ray detectable thread, sterile
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012944
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Fomed Industries Inc
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