Disposable Sterile Surgical Film
by Shandong Fengao Medical Technology Co., Ltd. 334 variants
Ref D4560U-3
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
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Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697067081120JX 06970670810640 | Date10 Jul 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- D4560U-3
- Primary DI / UDI-DI
- 06970670810640
- Basic UDI-DI
- 697067081120JX
- EMDN Code
- T02010101 Incision drapes, without antibacterial agent
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000026217
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
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Properties
Other properties (12)
- 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