Insilcare
by Suzhou Insilcare Polymer Material Co., Ltd. 2 variants
Ref 5.0cm×4.0MModel 5.0cmx4.0M
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 | Number697685272estape008JE 06976852721735 | Date24 Jan 2024 | 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- Withdrawn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
- Elastic Silicone Tape
- Model / Reference
- 5.0cmx4.0M, 5.0cm×4.0M
- Primary DI / UDI-DI
- 06976852721735
- Basic UDI-DI
- 697685272estape008JE
- EMDN Code
- H900299 Tapes, medical/surgical - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000038998
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Suzhou Insilcare Polymer Material Co., Ltd.
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