HandControl Kit
by Tianjin Plastics Research Institute Co., Ltd. China EUDAMED
Ref 06944803672726Model TPRI-S10-01, TPRI-S10-02, TPRIDP01-30-C, TPRI-S10-03
EMDN Z11039013
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6944803600150001HH | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CN25/00007713 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 30 Apr 2026
- Expires
- 13 Nov 2030
- Reason
- Add device or group
Specification
- Device Name
- Disposable High-pressure Angiographic Kit
- Model / Reference
- TPRI-S10-01, TPRI-S10-02, TPRIDP01-30-C, TPRI-S10-03, 06944803672726
- Primary DI / UDI-DI
- 06944803672726
- Basic UDI-DI
- 6944803600150001HH
- EMDN Code
- Z11039013 Angiographic injectors
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000031209
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Tianjin Plastics Research Institute Co., Ltd.
See all devices from Tianjin Plastics Research Institute Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED b8aab760-c824-455f-938e-3b03b94005ad