Medical Packaging materials
by TOPDENT Co., Ltd. China EUDAMED
Ref 11986
EMDN S01010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69744860700030001RD | Date23 Apr 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Packaging materials
- Model / Reference
- 11986
- Primary DI / UDI-DI
- 06974486070571
- Basic UDI-DI
- 69744860700030001RD
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000012237
- Authorised representative
- TopDent GmbH DE-AR-000005681
Other devices from TOPDENT Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 237b61be-0d09-4383-8924-74ed2811fa20