Guardian Perforated fenestrated drape
by Xuchang Zhengde Environstar Medical Products Co., Ltd.
Ref RFD-7276
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69317478SD000001GC 06931747826476 | Date12 May 2026 | 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- Withdrawn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
- Device Name
- Sterile Drapes
- Model / Reference
- RFD-7276
- Primary DI / UDI-DI
- 06931747826476
- Basic UDI-DI
- 69317478SD000001GC
- EMDN Code
- T02010101 Incision drapes, without antibacterial agent
- Device Class
- Class I
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000009427
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Xuchang Zhengde Environstar Medical Products Co., Ltd.
See all devices from Xuchang Zhengde Environstar Medical Products Co., Ltd. →
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