Automated Mannifold Kit
by Tianjin Plastics Research Institute Co., Ltd.
Ref 06944803672733Model TPRI-S10-01, TPRI-S10-02, TPRIDP01-30-C, TPRI-S10-03
Active
CE MDR
Valid until
13 Nov 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6944803600150001HH 06944803672733 | Date27 May 2026 | StatusActive |
Certificates
- CN25/00007713 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 30 Apr 2026
- Expires
- 13 Nov 2030
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable High-pressure Angiographic Kit
- Model / Reference
- TPRI-S10-01, TPRI-S10-02, TPRIDP01-30-C, TPRI-S10-03, 06944803672733
- Primary DI / UDI-DI
- 06944803672733
- Basic UDI-DI
- 6944803600150001HH
- EMDN Code
- Z11039013 Angiographic injectors
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000031209
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties
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