Bandage
by Anhui Xiaoshan Hope medical DEVICES Co., LTD 2 variants
Ref 80mm*4mModel 15mm*3.0m 25mm*3.0m 38mm*3.0m 50mm*3.0m 75mm*3.0m 100mm*3.0m150mm*3.0m 15mm*4.0m 25mm*4.0m 38mm*4.0m 50mm*4.0m 75mm*4.0m25mm*4.6m 38mm*4.6m 50mm*4.6m 75mm*4.6m 100mm*4.6m 150mm*4.6m 25mm*5.0m etc
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 | Number697676467BD004KG 06976764672743 | Date6 Oct 2023 | 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- Withdrawn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
- Bandage
- Model / Reference
- 15mm*3.0m 25mm*3.0m 38mm*3.0m 50mm*3.0m 75mm*3.0m 100mm*3.0m150mm*3.0m 15mm*4.0m 25mm*4.0m 38mm*4.0m 50mm*4.0m 75mm*4.0m25mm*4.6m 38mm*4.6m 50mm*4.6m 75mm*4.6m 100mm*4.6m 150mm*4.6m 25mm*5.0m etc, 80mm*4m
- Primary DI / UDI-DI
- 06976764672743
- Basic UDI-DI
- 697676467BD004KG
- EMDN Code
- M03030199 Elastic fixing bandages - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037849
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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