Elastic Bandage
by Changzhou Hualian Health Dressing Co., Ltd. 2 variants
Ref PS400108Model A-Nonwoven, B-Cotton, C-Elastic fabric
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69417626004V3 16941762602884 | Date27 Mar 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Self-adhesive Bandage
- Model / Reference
- A-Nonwoven, B-Cotton, C-Elastic fabric, PS400108
- Primary DI / UDI-DI
- 16941762602884
- Basic UDI-DI
- 69417626004V3
- EMDN Code
- M030402020101 Elastic support bandages, cohesive, extensible in one direction, high extensibility
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000021134
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Changzhou Hualian Health Dressing Co., Ltd
See all devices from Changzhou Hualian Health Dressing Co., Ltd →
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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