Barrier Sleeves
by TOPDENT Co., Ltd. China EUDAMED
Ref 403184
EMDN Z11079007
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69744860700040001RQ | Date23 Apr 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Barrier Sleeves
- Model / Reference
- 403184
- Primary DI / UDI-DI
- 06974486070304
- Basic UDI-DI
- 69744860700040001RQ
- EMDN Code
- Z11079007 Cassettes for x–ray films
- Device Class
- Class I
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000012237
- Authorised representative
- TopDent GmbH DE-AR-000005681
From the manufacturer
Manufacturer's product page: Barrier Sleeves
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 7539874d-edbd-403a-a9a2-e0bd002d35fc