Medial Ultrasound Gel
by Shanghai Shenfeng Medical&Health Articles Co., Ltd 17 variants
Ref 4kg Surgitech
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 | Number69506891GEL002LX 06950689130236 | Date9 Mar 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- Withdrawn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
- Medical Ultrasound Gel
- Model / Reference
- 4kg Surgitech
- Primary DI / UDI-DI
- 06950689130236
- Basic UDI-DI
- 69506891GEL002LX
- EMDN Code
- Z12010885 Instruments for ultrasonic surgery - consumables
- Device Class
- Class I
- EU market of registration
- Cyprus
Manufacturer details
- EUDAMED SRN
- CN-MF-000012676
- 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