Medical dry laser film
by Jiangsu Taike Medical Technology Co., Ltd 15 variants
Ref TK-JG-B 16KModel TK-JG-A 14in×17in、TK-JG-A 13in×17in、TK-JG-A 14in×14in、TK-JG-A 11in×14in、TK-JG-A 10in×14in、TK-JG-A 10in×12in、TK-JG-A 8in×10in、TK-JG-A A3、TK-JG-A A4、TK-JG-A 16K、TK-JG-A B5; 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 | Number697502290TKMDLFQ7 06975022901205 | 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- Withdrawn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
- Device Name
- Medical dry laser film
- Model / Reference
- TK-JG-A 14in×17in、TK-JG-A 13in×17in、TK-JG-A 14in×14in、TK-JG-A 11in×14in、TK-JG-A 10in×14in、TK-JG-A 10in×12in、TK-JG-A 8in×10in、TK-JG-A A3、TK-JG-A A4、TK-JG-A 16K、TK-JG-A B5, etc, TK-JG-B 16K
- Primary DI / UDI-DI
- 06975022901205
- Basic UDI-DI
- 697502290TKMDLFQ7
- EMDN Code
- Z130106 Dry thermal printer 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