Neo Plasma Sterilization Rolls
by Anqing YIPAK Packaging Material Co., Ltd. EUDAMED
Active
Ref YTR-350Model YTR-050 YTR-075 YTR-100 YTR-120 YTR-125 YTR-150 YTR-200 YTR-250YTR-300 YTR-350 YTR-380 YTR-400 YTR-450 YTR-500 YTR-550 YTR-600
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69702568400068K | Date1 Jun 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Plasma Sterilization Rolls
- Model / Reference
- YTR-050 YTR-075 YTR-100 YTR-120 YTR-125 YTR-150 YTR-200 YTR-250YTR-300 YTR-350 YTR-380 YTR-400 YTR-450 YTR-500 YTR-550 YTR-600, YTR-350
- Primary DI / UDI-DI
- 06970256846575
- Basic UDI-DI
- 69702568400068K
- Direct Marketing DI
- 06970256846575
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- CN-MF-000025130
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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