Disposable medical sterile surgical film
by Shandong Dermcosy Medical Supplies Co., Ltd. 7 variants
Ref MDRModel E type/U type
Active
CE MDR
Valid until
10 Jul 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCN25/00004696 | Date10 Jul 2025 | StatusActive |
Certificates
- CN25/00004696 Active
Quality assurance EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 10 Jul 2025
- Expires
- 10 Jul 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable medical sterile surgical film
- Model / Reference
- E type/U type, MDR
- Primary DI / UDI-DI
- 16976113710031
- Basic UDI-DI
- 697611371A000139
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000036662
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Shandong Dermcosy Medical Supplies Co., Ltd.
See all devices from Shandong Dermcosy Medical Supplies 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