Side Drape
by Xuchang Zhengde Environstar Medical Products Co., Ltd. 19 variants
Ref B613-02
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Side Drape is a non-sterile, disposable drapery designed for use in medical settings. Made from high-quality materials, it provides a sterile environment for surgical procedures and post-operative care.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69317478NSD00000146 06931747812899 | Date10 Feb 2026 | 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- Withdrawn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
- Non sterile drapes
- Model / Reference
- B613-02
- Primary DI / UDI-DI
- 06931747812899
- Basic UDI-DI
- 69317478NSD00000146
- EMDN Code
- T020199 Surgical drapes - other
- Device Class
- Class I
- EU market of registration
- Sweden
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 (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