Medical dry film
by Jiangsu Taike Medical Technology Co., Ltd China EUDAMED
Ref TK-808（8×10）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
EMDN Z130101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697502290TKMDFMS | Date3 Jun 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical dry film
- 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-808（8×10）in
- Primary DI / UDI-DI
- 06975022900352
- Basic UDI-DI
- 697502290TKMDFMS
- EMDN Code
- Z130101 General purpose x-ray films
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041908
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED de852ded-6d10-4e67-87c8-50bc3884aee7