Sterilization pouch/roll
by Anqing Topeak Medical Co., Ltd 22 variants
Model TOP057100 TOP070260 TOP090165 TOP090260 TOP135280 TOP300430 TOP190360 TOP500630 TOP050200 TOP075200 TOP100200 TOP150200 TOP200200 TOP250200 TOP300200 TOP400200 TOP500200 TOP075100 TOP100100 TOP150100 TOP200100 TOP250100 TOP300100 TOP10070 TOP15070 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 | Number697596524SP01TQ 06975965240072 | Date1 Feb 2023 | 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- Withdrawn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
- Sterilization pouch/roll
- Model / Reference
- TOP057100 TOP070260 TOP090165 TOP090260 TOP135280 TOP300430 TOP190360 TOP500630 TOP050200 TOP075200 TOP100200 TOP150200 TOP200200 TOP250200 TOP300200 TOP400200 TOP500200 TOP075100 TOP100100 TOP150100 TOP200100 TOP250100 TOP300100 TOP10070 TOP15070 etc
- Primary DI / UDI-DI
- 06975965240072
- Basic UDI-DI
- 697596524SP01TQ
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000032445
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Anqing Topeak Medical 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