Drape Irrigation Pouch 40x35cm S/A Clear Film
by Xuchang Zhengde Environstar Medical Products Co., Ltd.
Ref RFEO03-7715
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 | Number69317478NFCP000001KX 06931747860135 | Date13 May 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- Withdrawn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 Fluid collection pouch
- Model / Reference
- RFEO03-7715
- Primary DI / UDI-DI
- 06931747860135
- Basic UDI-DI
- 69317478NFCP000001KX
- EMDN Code
- A060302 Collection bags for urological and arthroscopic washings, single-use
- 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
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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