Non-woven Patch
by Henan Kangdi Medical Devices Co., Ltd.
Ref 2x2cmModel 2x2cm; 3x3cm; 3.5x3cm; 3.5x4.5cm; 3.7x8cm; 4x4cm; 4.5x4.5cm; 5x5cm;5x6cm; 5x7cm;5x8cm; 5x10cm;5x12cm; 5.5x1.6cm; 5x7cm;6x6cm; 6x7cm; 6x8cm; 6x9cm; 6x10cm; 6x12cm; 6.5x2.0cm; 6.5x4.2cm; 6.6x1.9cm; 7x2.5cm; 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 | Number69505629Patch001CB 06950562990100 | Date30 Aug 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- Withdrawn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
- Non-woven Patch
- Model / Reference
- 2x2cm, 3x3cm, 3.5x3cm, 3.5x4.5cm, 3.7x8cm, 4x4cm, 4.5x4.5cm, 5x5cm, 5x6cm, 5x7cm, 5x8cm, 5x10cm, 5x12cm, 5.5x1.6cm, 6x6cm, 6x7cm, 6x8cm, 6x9cm, 6x10cm, 6x12cm, 6.5x2.0cm, 6.5x4.2cm, 6.6x1.9cm, 7x2.5cm, etc
- Primary DI / UDI-DI
- 06950562990100
- Basic UDI-DI
- 69505629Patch001CB
- EMDN Code
- M020299 Non-woven gauzes - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000013059
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Henan Kangdi Medical Devices Co., Ltd.
See all devices from Henan Kangdi Medical Devices 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