Medical dry film
by Jiangsu Taike Medical Technology Co., Ltd 17 variants
Ref TK-880（10×14）inModel TK-410（14×17）in、TK-410（13×17）in、TK-410（11×14）in、TK-410（10×14）in、TK-410（10×12）in、TK-410（8×10）in、TK-410-A3、TK-410-A4、etc
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
This Medical Dry Film device is a sterile and reliable alternative for skin biopsies, offering high accuracy and precision in medical diagnosis. With its rugged construction and easy-to-use design, it's perfect for busy healthcare professionals who need to perform complex procedures quickly and efficiently.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697502290TKMDFMS 06975022900239 | Date3 Jun 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- Withdrawn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
- Model / Reference
- TK-410（14×17）in、TK-410（13×17）in、TK-410（11×14）in、TK-410（10×14）in、TK-410（10×12）in、TK-410（8×10）in、TK-410-A3、TK-410-A4、etc, TK-880（10×14）in
- Primary DI / UDI-DI
- 06975022900239
- Basic UDI-DI
- 697502290TKMDFMS
- EMDN Code
- Z130101 General purpose x-ray films
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041908
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Jiangsu Taike Medical Technology Co., Ltd
See all devices from Jiangsu Taike Medical Technology 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