barrier film
by Across Industrial Co., Ltd 24 variants
Ref 240117Model 240101/240102/240103/240104/240105/240106/240107/240108/240109/240110/240111/240112/240113/240114/240115/240116/240117/240118/240119/240120/240121/240122 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 | Number697842977ZWBF38 06978429770634 | Date15 Apr 2025 | 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- Withdrawn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
- barrier film
- Model / Reference
- 240101/240102/240103/240104/240105/240106/240107/240108/240109/240110/240111/240112/240113/240114/240115/240116/240117/240118/240119/240120/240121/240122 etc, 240117
- Primary DI / UDI-DI
- 06978429770634
- Basic UDI-DI
- 697842977ZWBF38
- EMDN Code
- T030102 Cover sheaths, instruments and equipments
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000047003
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Across Industrial 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